DELHI PHARMACUTICAL SCIENCES & RESEARCH UNIVERSITY Govt ...dpsru.edu.in/.../bootstrap/files/M.Pharm-All-Sem-Syllabus-new.pdf · DELHI PHARMACUTICAL SCIENCES & RESEARCH UNIVERSITY

DELHI PHARMACUTICAL SCIENCES & RESEARCH UNIVERSITY

Govt. of NCT of Delhi, New Delhi- 110017, India

Syllabus for

Master of Pharmacy Program

(w.e.f. 2016-2017 Session)

MASTER OF PHARMACY

INDEX

S. No SPECIALIZATION

1. PHARMACOLOGY

2. PHARMACEUTICAL CHEMISTRY

3. PHARMACEUTICS

4. PHARMACOGNOSY AND PHYTOCHEMISTRY

5. QUALITY ASSURANCE

6. DRUG REGULATORY AFFAIRS

7. CLINICAL RESEARCH

1. M. PHARM. PHARMACOLOGY COURSE OF STUDY AND SCHEME OF EXAMINATION

Semester Paper Code:

Subject Periods Credit

Units Evaluation scheme

L T P/S Internal# External Total

I

MPC 101

Modern Analytical Techniques 4 - - 4 20 80 100

MPC 101P

Modern Analytical Techniques Practical - - 8 4 20 80 100

MPCL 102

Emerging Trends in Molecular and Therapeutic Pharmacological Sciences-I

3 1 - 4 20 80 100

MPCL 102P

Emerging Trends in Molecular and Therapeutic Pharmacological Sciences-I Practical

- - 8 4 20 80 100

MPCL 103

Introduction to Clinical Pharmacology 3 1 - 4 20 80 100

YGS 104

Yogic Science 1 - - 2 - 50 50

YGS 104P

Yogic Science Practical - - 1 2 - 50 50

Total 11 2 17 24 100 500 600

II

MPC 201

Drug Regulatory Affairs & Intellectual Property Rights

4 - - 4 20 80 100

MPC 201S

Scientific Writing and Seminar Presentation

2 - 6 4 100 0 100

MPCL 202

Emerging Trends in Molecular and Therapeutic Pharmacological Sciences-II

3 1 - 4 20 80 100

MPCL 203

Pharmacological Screening Methods & Toxicology

3 1 - 4 20 80 100

MPCL 203P

Pharmacological Screening Methods & Toxicology Practical

- - 8 4 20 80 100

Total 12 2 14 20 180 320 500 # Internal examination will be of 15 marks + 5 marks for attendance, behavior and extracurricular activities.

2. M. PHARM. PHARMACEUTICS

Semester Paper Code: Subject

Periods Credit Units

Evaluation scheme L T P/S Internal# External Total

I

MPC 101


MPC 101P


MPCU 102

Product Development 3 1 - 4 20 80 100

MPCU 102P

Product Development Practical - - 8 4 20 80 100

MPCU 103

Bio-Pharmaceutics and Pharmacokinetics 3 1 - 4 20 80 100

YGS 104


YGS 104P


Total 11 2 17 24 100 500 600

II

MPC 201


4 - - 4 20 80 100

MPC 201S


2 - 6 4 100 0 100

MPCU 202

Industrial Pharmacy & Practices 3 1 - 4 20 80 100

MPCU 203

Advances in Drug Delivery System 3 1 - 4 20 80 100

MPCU 203P

Advances in Drug Delivery System Practical

- - 8 4 20 80 100


3. M. PHARM. PHARMACEUTICAL CHEMISTRY




I

MPC 101


MPC 101P


MPCH 102

Pharmaceutical Chemistry-I (Advanced Organic Chemistry-I)

3 1 - 4 20 80 100

MPCH 102P

Pharmaceutical Chemistry-I Practical - - 8 4 20 80 100

MPCH 103

Pharmaceutical Chemistry-II (Advanced Medicinal Chemistry)

3 1 - 4 20 80 100

YGS 104


YGS 104P


Total 11 2 17 24 100 500 600

II

MPC 201


4 - - 4 20 80 100

MPC 201S


2 - 6 4 100 0 100

MPCH 202

Pharmaceutical Chemistry-III (Advanced Organic Chemistry-II)

3 1 - 4 20 80 100

MPCH 203

Pharmaceutical Chemistry-IV (Drug Designing and Medicinal Chemistry)

3 1 - 4 20 80 100

MPCH 203P

Pharmaceutical Chemistry-II Practical - - 8 4 20 80 100


4. M. PHARM. PHARMACOGNOSY AND PHYTOCHEMISTRY




I

MPC 101


MPC 101P


MPCG 102

Pharmacognosy & Phytochemistry-I (Advances in Pharmacognosy & Phytochemistry)

3 1 - 4 20 80 100

MPCG 102P

Pharmacognosy & Phytochemistry-I (Advances in Pharmacognosy & Phytochemistry) Practical

- - 8 4 20 80 100

MPCG 103

Pharmacognosy & Phytochemistry-II (Medicinal Plant Cultivation) 3 1 - 4 20 80 100

YGS 104 Yogic Science 1 - - 2 - 50 50

YGS 104P Yogic Science Practical - - 1 2 - 50 50

Total 11 2 17 24 100 500 600

II

MPC 201

Drug Regulatory Affairs & Intellectual Property Rights 4 - - 4 20 80 100

MPC 201S


2 - 6 4 100 0 100

MPCG 202

Pharmacognosy and Phytochemistry-III (Standardization of Natural Products and Formulations)

3 1 - 4 20 80 100

MPCG 203

Pharmacognosy and Phytochemistry-IV (Nutraceuticals, Herbal Cosmetics & Phytochemical Techniques)

3 1 - 4 20 80 100

MPCG 203P

Pharmacognosy and Phytochemistry-IV (Nutraceuticals, Herbal Cosmetics & Phytochemical Techniques) Practical

- - 8 4 20 80 100


5. M. PHARM. QUALITY ASSURANCE




I

MPC 101


MPC 101P


MPQA 102

Quality Management 3 1 - 4 20 80 100

MPQA 102P

Quality Assurance Practical - - 8 4 20 80 100

MPQA 103

Product Development 3 1 - 4 20 80 100

YGS 104


YGS 104P


Total 11 2 17 24 100 500 600

II

MPC 201


4 - - 4 20 80 100

MPC 201S


2 - 6 4 100 0 100

MPQA 202

Documentation and Regulatory Writing 3 1 - 4 20 80 100

MPQA 203

Pharmaceutical Validation 3 1 - 4 20 80 100

MPQA 203P

Quality Assurance Practical - - 8 4 20 80 100


6. M. PHARM. DRUG REGULATORY AFFAIRS




I

MPC 101


MPC 101P


MPDR 102

National And International Drug Approval Regulations

3 1 - 4 20 80 100

MPDR 102P

Regulatory Affairs Practical - - 8 4 20 80 100

MPDR 103

Clinical Research Regulations 3 1 - 4 20 80 100

YGS 104


YGS 104P


Total 11 2 17 24 100 500 600

II

MPC 201


4 - - 4 20 80 100

MPC 201S


2 - 6 4 100 0 100

MPDR 202

Documentation and Regulatory Writing 3 1 - 4 20 80 100

MPDR 203

Biologics and Medical Devices Regulations

3 1 - 4 20 80 100

MPDR 203P

Regulatory Affairs Practical - - 8 4 20 80 100


7. M. PHARM. CLINICAL RESEARCH




I

MPC 101


MPC 101P


MPCR 102

Basic Principles of Clinical Research 3 1 - 4 20 80 100

MPCR 103

Pharmacovigilence: Safety Monitoring of Drugs

3 1 - 4 20 80 100

MPCR 103P

Pharmacovigilence: Safety Monitoring of Drugs Practical

- - 8 4 20 80 100

YGS 104


YGS 104P


Total 11 2 17 24 100 500 600

II

MPC 201


4 - - 4 20 80 100

MPC 201S


2 - 6 4 100 0 100

MPCR 202

Pharmacoeconomics and Outcomes Research

3 1 - 4 20 80 100

MPCR 203

Clinical Research Methodology 3 1 - 4 20 80 100

MPCR 203P

Clinical Research Methodology Practical - - 8 4 20 80 100


MODERN ANALYTICAL TECHNIQUES

M. Pharm. Ist Semester

Paper code: MPC101 This paper is common to Ist semester of all branches

1. NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY:

Principle and Instrumentation Techniques, solvents, chemical shift and factors affecting chemical shift, spin-spin coupling, chemical shift reagents, coupling constant, spin-spin decoupling, Pascal triangle, FT-NMR, 2D-NMR,NOE, NOESY, COSY and applications in Pharmacy. Interpretation of NMR spectra.13C-NMR-Introduction, Natural abundance, 13C-NMR spectral study and its structural applications.

2. INFRARED SPECTROSCOPY: Introduction, basic principles, vibrational frequency and factors influencing vibrational frequency, FT-IR-theory, instrumentation and sampling techniques, interpretation of IR spectra and its applications in Pharmacy, Attenuated Total Reflectance (ATR).

3. UV-VISIBLE SPECTROSCOPY: Brief review of electromagnetic spectrum and absorption of radiations. Chromophore, absorption law and limitations. Theory of electronic spectroscopy, absorption by organic molecules, choice of solvent and solvent effects, modern instrumentation – Principle, design, working and Applications of UV-Visible spectroscopy (qualitative and quantitative analysis), Woodward-Fieser rules for 1,3- butadienes, cyclic dienes and α, β-carbonyl compounds.

4. FLAME EMISSION SPECTROSCOPY AND ATOMIC ABSORPTION SPECTROSCOPY: Principle, instrumentation, interferences and applications in Pharmacy.

5. SPECTROFLUORIMETRY: Theory, instrumentation, advantages, relationship of chemical structure to fluorescence spectra, solvent effect, effect of acids and bases on fluorescence spectra, concentration effects, factors affecting fluorescence intensity, fluorescence quenching, comparison of fluorescence and UV-Visible absorption methods and applications in Pharmacy.

6. MASS SPECTROSCOPY: Basic principles and instrumentation, ion formation and types, fragmentation processes and fragmentation pattern, Chemical ionization mass spectroscopy (CIMS), Field Ionization Mass Spectrometry (FIMS), Fast Atom Bombardment MS (FAB MS), Matrix Assisted laser desorption / Ionization MS (MALDI-MS), GC-MS, interpretation of spectra and applications in Pharmacy.

7. THERMAL METHODS OF ANALYSIS: Theory, instrumentation and applications of Thermo Gravimetric Analysis (TGA), Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC) and Thermo Mechanical Analysis (TMA).

8. ELECTRON SPIN RESONANCE SPECTROSCOPY: Theory and Principle, Limitations of ESR, choice of solvent, g-values, hyperfine splitting, instrumentation, difference between ESR & NMR and applications.

9. CHROMATOGRAPHIC TECHNIQUES: i. Gas Chromatography: Theory and principle, column operation, instrumentation,

derivatisation methods and applications in Pharmacy. ii. High Performance Liquid Chromatography: Principle, instrumentation, solvents used,

elution techniques and applications in Pharmacy. iii. TLC, HPTLC and Super Critical Fluid Chromatography (SFC): Theory and Principle,

instrumentation, elution techniques and pharmaceutical applications. 10. RADIOIMMUNOASSAY: Introduction, Principle, Theory and Methods in Radio Immuno Assay and Applications of RIA Techniques 11. OPTICAL ROTARY DISPERSION:

Principle, Plain curves, curves with cotton effect, octant rule and its applications with example, circular dichroism and its relation to ORD

12. X-RAY DIFFRACTION METHODS: Introduction, generation of X-rays, X-ray diffraction, Bragg’s law, X-ray powder diffraction and applications.

Text and References

1. Spectrometric Identification of Organic compounds - Robert M Silverstein, Sixth edition, John Wiley & Sons. 2. Principles of Instrumental Analysis - Douglas A Skoog, F. James Holler, Timothy A. Nieman, 5th edition, Eastern press, Bangalore. 3. Instrumental methods of analysis – Willard, CBS publishers. 4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS Publishers, New Delhi, 1997. 5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS. 6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd Edition, CBS Publishers, New Delhi. 7. Pharmaceutical Analysis- Modern methods – Part B - J W Munson, Volume 11, Marcel Dekker Series. 8. Instrumental Methods of Chemical Analysis –B. K. Sharma. 9. HPTLC–Quantitative Analysis of Pharmaceutical Formulations–P. D. Sethi. 10. Spectroscopy of Organic Compounds by P. S. Kalsi. 11. Elemental organic spectroscopy- Y.R.Sharma

MODERN ANALYTICAL TECHNIQUES PRACTICAL


Paper code: MPC101P

This paper is common to Ist semester of all branches

1. Analysis of Pharmacopoeial compounds and their formulations by UV Vis spectrophotometer, RNA & DNA estimation.

2. Simultaneous estimation of multi component containing formulations by UV spectrophotometry.

3. Experiments based on HPLC. 4. Estimation of riboflavin/quinine sulphate by fluorimetry. 5. Estimation of sodium/potassium by flame photometry. 6. Estimation of elements and functional groups in organic natural compounds. 7. Isolation, characterization like melting point, mixed melting point, molecular weight

determination, functional group analysis, co-chromatographic technique for identification of isolated compounds and interpretation of UV and IR data.

8. Comparison of absorption spectra by UV and Woodward–Fieser rules. 9. Interpretation of organic compounds by FT-IR. 10. Interpretation of organic compounds by NMR. 11. Interpretation of organic compounds by MS. 12. Determination of purity by DSC in pharmaceuticals. 13. Determination of log P, MR, hydrogen bond donors and acceptors of selected drugs using

softwares. 14. Calculation of ADMET properties of drug molecules and its analysis using softwares

Pharmacophore modelling.

Text and References 1. M. Orchin and H.H. Jaffe – Theory & application of ultra- violet spectroscopy. (John Wiley & Sons.

N.Y) 2. Silverstein, Basseler, Morril- Spectroscopic identification of organic compounds (John Wiley & Sons). 3. Willard, Merritt, Dean – Instrumental methods of analysis (CBS Publishers and Distributors, Delhi). 4. J.R. Dyer – Application of absorption Spectroscopy of Organic Compounds (Prentice Hall, London). 5. L.M. Jackmann and B.D. Sternhell – Application of NMR spectroscopy in organic chemistry

(Pergamon Press, London.). 6. R.J. Hamilton- Introduction to High Performance Liquid Chromatography.(Chapman and Hall,

London ). 7. Introduction to Spectroscopy, 3

rd edition, Pavia, Lampman, Kriz, Thomson Publisher.

8. Analytical chem.., 2nd

edition by Kellner, Mermet, Otto, Valcarcel Wiley ECH. 9. P.D. Sethi – Quantitative Analysis of Drugs in Pharmaceutical formulations (VBS Publishers, Delhi). 10. Pharmacopoeia of India ; United State Pharmacopoeia; British Pharmacopoeia 11. A.H. Beckett, J.B. Stenlake – Practical Pharmaceutical Chemistry, Part I and Part II (CBS Publishers

Delhi). 12. Organic Spectroscopy by William Kemp

YOGIC SCIENCE


Paper Code: YGS104 This paper is common to Ist semester of all branches

History and philosophy of Yoga Introduction of yoga in the light of health The history and Tradition of Yoga Importance of yoga in Modern age

Principles and practice of yoga and Meditation � Asana, Pranayama, Mudra, Bandh, Meditation, Chakra Anatomy and Physiology of yoga � Physiological effect of yoga with special reference to Pranayama and Bandh � Effects of yoga on skeleton and muscular system Nutrition in Yoga � Relevance of yogic nutrition in health � Diet according to season (Ritucharya) � Health eating plans and recipes in some life style diseases Yoga as Therapeutics � Principles of Yoga Therapy � Life style Disease regulation by Yoga � Meditation and Therapy � Stress and Personality � Yogic way of life Text and References 1. Asana Pranayama Mudra Bandha by Swami Satyananda Saraswati. Publisher: Yoga Publication Trust, Munger, Bihar, India 2. Yoga on Hypertension by Swami Shankardevanand. Publisher: Yoga Publication Trust, Munger, Bihar, India. 3. Essence of Yoga by Sri Swami Sivananda Saraswati. Publisher: The Divine Life Society, Uttarakhand, India 4. The Yoga Sutras of Patanjali by Swami Venkatesanand. Publisher: Motilal Banarsidass Publishers Private Limited, New Delhi, India 5. Hatha Yoga by Swami Sivananda. Publisher: The Divine Life Society, Uttarakhand, India 6. Gheranda Samhita by Swami Niranjanananda Saraswati. Publisher: Yoga Publication Trust, Munger, Bihar, India 7. Essence of Pranayama by Dr Shrikrishna. Publisher: Kaivalyadhama, Pune, India.

YOGIC SCIENCE PRACTICAL Paper Code: YGS104P

This paper is common to Ist semester of all branches

Asana 1 Bhujangasana (cobra pose) 2 Tadasana (palm tree pose) 3 Tiryaka Tadasana (swaying palm tree pose) 4 Nukasana (boat pose) 5 Paschimottanasana (back stretching pose) 6 Janu sirshasana (head to knee pose) 7 Eka padasana (one foot pose) 8 Chakrasana (wheel pose) 9 Brahmacharyasana (celibate's pose) 10 Dhanurasana (bow pose) 11 Shalabhasana (locust pose) 12 Sarpasana (snake pose) 13 Padmasana (lotus posr) 14 Vajrasana (thunderbolt pose) 15 Dwikonadana (doubls angle pose) 16 Surya Namaskar 17 Ardha Chandrasana (crescent moon pose) 18 Ardha Matsyendrasana (half spinal pose) 19 Ushtrasana (camal pose) 20 Uttanpadasana (raised legs pose) 21 Natrajasana (Lord Shiva's dance pose)

Pranayama 1 Narishodhan 2 Ujjayi 3 Kapalbhati 4 Bhastrika 5 Bharamri 6 Surya Bhedi 7 Chandra Bhedi 8 Sheetali (cooling breath)

Bandh 1 Jalandhara Bandh (throat lock) 2 Uddiyan Bandh (abdominal contraction) 3 Moola Bhandh (perineum contraction) 4Maha Bandh (great lock)

Mudra 1 Giyan Mudra (chin mudra) 2 Hridaya Mudra (heart gesture) 3 Bhoochri Mudra (gazing into nothing) 4 Yoga Mudra (Attitude of psychic union) 5 Shambhavi Mudra (eyebrow centre gazing)

DRUG REGULATORY AFFAIRS & INTELLECTUAL PROPERTY RIGHTS

M. Pharm. IInd Semester

Paper code: MPC201 This paper is common to IInd semester of all branches

1. Clinical Trials, its regulations and Pharmacovigilance: Phases of clinical trials; BA-BE studies; Schedule Y and brief overview on ICH – GCP. Pharmacovigilance: aims and need for pharmacovigilance, types, predisposing factors and mechanism of adverse drug reactions (ADRs). Detection, reporting,management and monitoring of ADRs, role of pharmacists in pharmacovigilance.

2. National & International Drug Regulations: CDSCO and State licensing authority, their functions and responsibilities. Overview of the drug regulatory aspects in countries- e.g. India, US and Europe. IND (Investigational New Drug), NDA (New Drug Application), Generic Drug ANDA Applications – an overview in India and other countries. Brief overview of CTD formats of dossiers, E-submission, US DMF (various types), orange book, purple book and Hatch Waxman Act and amendments.

3. Intellectual Property Rights & Regulations: Overview of Intellectual Properties, their types and importance of intellectual property protection. Patents: Requirement of patenting, patent specifications and claims, Indian Patent act 1970 and amendments. Patent search, analysis, drafting and stages of filing patent at national level. Patent licensing, abuse of patents, infringements analysis, Compulsory licensing.

4. International Treaties & IPR Organizations: Paris Conventions, Patent Cooperation Treaty (PCT) – introduction, application and general rules. Patent search, analysis, drafting and stages of filing patent at international level. Introduction to concept behind WIPO / WTO / TRIPS / GATT / GATS system & Uruguay Round.

References: 1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader

Kaufer, Marcel Dekker series, Vol.143, Pharmaceutical Regulatory Process, Edited by Ira R. Berry Marcel Dekker Series,Vol.144

2. New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences, Vol.190.

3. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc. 4. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69, Marcel Dekker

Series, 1995. 5. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and related materials

Vol I & II, 2nd edition, WHO Publications, 1999.

6. Good Manufacturing-Practices for Pharmaceuticals, by Graham Bunn and Joseph 6th Ed. D.Nally (Dec 26, 2006)

7. Country specific Regulatory Guidelines (available from internet): CDSO publications and updates of drug and Cosmetics act and rules (Govt. of India); CDER Publications and Guidance; EMEA Publications and Guidance; ICH guidelines

8. http://www.ipindia.nic.in/; https://www.uspto.gov/; http://www.wipo.int/portal/en/index.html; https://www.wto.org/

http://www.ipindia.nic.in/�

https://www.uspto.gov/�

http://www.wipo.int/portal/en/index.html�

https://www.wto.org/�

SCIENTIFIC WRITING AND SEMINAR PRESENTATION

Paper code: MPC201S This paper is common to IInd semester of all branches

1. Formation of Research Problem a) Research Process: To determine what type of research to be done, plan of research work. b) Selection of research area, prioritization of research. c) Literature review: importance and methods, sources, d) Objectives and scope of work, developing research plan and schedule: e) Scheduling constraints, steps, problems in scheduling, limitations.

2. Research Deliverables a) Various Forms of Publication: Thesis, paper, research proposal. b) Thesis Writing: Introduction, literature review or state-of-the-art, researchapproach

(methodology), results or findings, discussions, conclusions,scope for future work, references, appendices.

c) Presentation: Poster, thesis, proposal, and paper.

3. Seminar Presentation by students: Any reputed journal research article discussion in form of presentation. Key points: Content of presentation; presentation skills and presentation format.

References:

The choice of books & other literature material depends on the topic selected & is left with the concerned faculty member.

SYLLABUS FOR M. PHARM PHARMACOLOGY

M. Pharm.- Ist Semester

EMERGING TRENDS IN MOLECULAR AND THERAPEUTIC PHARMACOLOGICAL SCIENCES-I

Paper code: MPCL102 1. Pharmacokinetics Drug absorption, Drug distribution, elimination of drugs, Bioavailability and Bioequivalence of drug products, Biotransformation of drugs, Factors influencing drug metabolism 2. Pharmacodynamics General principles of pharmacodynamics- agonism, antagonism, neurotransmission, Cell signalling and organization of signal transduction pathway, (G- proteins, phosphatidyl inositol cyclic nucleotides, Calcium and calcium binding proteins, phospholipase). 3. Systemic Pharmacology A detailed study of the mechanism of action, pharmacology, drug interaction, rationale and therapeutic uses of drugs used in: a) CNS – General anesthetics, sedatives, hypnotics. Drugs used to treat anxiety, depression,

psychosis, mania, epilepsy, neurodegenerative diseases (AD, PD, Huntington’s chorea, Multiple Sclerosis).

b) CVS- Diuretics, anti ischemics, antihypertensives, antiarrythmics, drugs for heart failure and dyslipidiemia. c) Autocoid Pharmacology- histamine, serotonin, kinins, prostaglandins, opioid autocoids. Therapeutic agents for management of allergy, asthma, COPD. d) GIT pharmacology- Antiulcer, prokinetics, antiemetics, antidiarrhoeal, constipation and irritable bowel syndrome. e) Analgesics and anti-inflammatory agents. f) Hormones and hormone antagonists with Special focus on thyroid & anti-thyroids, insulin

& drugs for diabetes mellitus, steroids. Adrenal gland, Pituitary glands, Ovary and Testes hormones.

Text and References:

1. B.G. Katzung, Basic and Clinical Pharmacology, Lange Medical Publications, 1998. 2. Goodman and Gilman’s The Pharmacological Basis of Therapeutics- Mc Millan

Publishing Co. Inc. 3. D.R. Laurence and P.N.Bennett, Clinical Pharmacology, E.L.B.S./ Churchill

Livingstone, U.K. 4. H.P.Rang and M.M. Dale, Pharmacology, ELBS/Churchill Livingstone. 5. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu. 6. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for

Industrial Scientists

EMERGING TRENDS IN MOLECULAR AND THERAPEUTIC PHARMACOLOGICAL SCIENCES-I PRACTICAL

Paper code: MPCL102P

1. Experiments based on:

i. Animal Handling ii. Drug administration

2. Experiments based on:

i. Drug absorption

ii. Drug distribution

iii. Elimination of drugs

iv. Bioavailability and bioequivalence of drug products

v. Biotransformation of drugs

3. Studies on Animal models CNS, CVS, GIT, Autocoid, Endocrine and anticancer

agents.

4. Microbiological Screening of Antibacterial & Antifungal agents.


1. Drug Screening Methods by SK Gupta, 3rd Edition, JAYPEE Publication 2. Herbal Drug Technology 2nd Edition by S S Agrawal, M Paridhavi. Orient BlackSwan

Pvt. Ltd. 3. Screening methods in Pharmacology by Robert Turner, A. 4. Drug Discovery and Evaluation by Vogel HG. 5. Fundamentals of experimental pharmacology by M. N. Ghosh.

INTRODUCTION TO CLINICAL PHARMACOLOGY

Paper code: MPCL103

1. New approaches in drug discovery

Strategies and approaches employed in drug discovery, Combinatorial chemistry,

Pharmacogenomics, High throughput screening, cassette dosing, Proteomics, Array

technology, Chronopharmacology & Reverse Pharmacology. Toxicokinetics- Importance and

applications of toxicokinetic studies.

2. Rational Drug Design

Traditional vs. rational drug design, Methods followed in traditional drug design, High

throughput screening, Concepts of Rational Drug Design, Rational Drug Design Methods.

Structure and Pharmacophore based approaches. Virtual Screening techniques: Drug likeness

screening, Concept of pharmacophore mapping and pharmacophore based Screening.

3. Drug development process

Drugs & Cosmetics act, Schedule Y and M, clinical trial registry of India, Investigational

new drug development, new drug development, abbreviated new drug development, Clinical

drug development phases-definition, types of clinical trial, phase I, phase II, phase III and

phase IV studies, post marketing surveillance of drugs. Basic concept of Pharmacovigilance,

Pharmacoeconomics and Pharmacoinformatics.

4. Good Clinical Practice (GCP)

Origin of GCP, Requirements of GCP compliance, Guidelines for GCP, guidelines of ICH,

guidelines of ICMR, Ensuring GCP, Documentation of GCP practice, Audit of GCP

compliance.

5. Biostatistics in Clinical Trials

Variables, mean, median, mode, range, variance, standard deviation, sample variance,

student-t-distribution, chi-square distribution, linear regression & correlation, Randomization,

Stratified Randomization, Blinding, Sample size & ANOVA analysis.


1. Drug Discovery and Clinical Research by SK Gupta. JAYPEE Publication. 2. Basic Principles of Clinical Research Methodology by SK Gupta. JAYPEE

Publication. 3. Psychopharmacology- The Third Generation & Progress- Herbert Y. Meltzer, Laven

Press

4. B.G. Katzung, Basic and Clinical Pharmacology, Lange Medical Publications, 1998. 5. H.P.Rang and M.M. Dale, Pharmacology, ELBS/Churchill Livingstone. 6. Biostatistics in a Nut Shell for Medical Researchers by Sandheep Sugathan.

Educreation Publishing. 7. Introduction to Biostatistics and Research Methods by Sundar Rao, Richard 5th

Edition. PHI Learning Pvt. Ltd-New Delhi. 8. J. Rick Turner. New drug development design, methodology and, analysis. John

Wiley & Sons, Inc., Hoboken, New Jeney.

M. Pharm.- IInd Semester

EMERGING TRENDS IN MOLECULAR AND THERAPEUTIC PHARMACOLOGICAL SCIENCES-II

(Paper code: MPCL202) 1. Systemic Pharmacology A detailed study of the mechanism of action, pharmacology, drug interaction, therapeutic uses of drugs used in:

a) ANS- Parasympathomimetics and Parasympatholytics, sympathomimetics and sympatholytics, agents acting at neuromuscular junction and ganglia.

b) Anesthetics. c) Effect of drug on blood constituents. d) Immunopharmacology- allergy, hypersentitivity and immunomodulation. e) Chemotherapeutic agents (antiprotozoals, antileishmeniasis, anti-tubercular, anti-

leprotic, antiviral, anti-fungal, antiamoebics, anthelmintics, and Anti-cancer drugs). f) Drug based on genetic factors

2. Miscellaneous Role of free radicals in etiopatholgy of various diseases and Protective activity of antioxidants. Regulatory mechanisms of Cell cycle and Cell Death - Apoptosis, Necrosis. Pharmacology of drugs for special population (geriatric, pediatric, pregnant, lactating), Nitric oxide-its role in physiology and pathophysiology, drugs acting via non-noradrenergic, non-cholinergic transmitter (NANC).


1. Goodman and Gilman’s The Pharmacological Basis of Therapeutics- Mc Millan Publishing Co. Inc.

2. H. P. Rang and M. M. Dale, Pharmacology, ELBS/Churchill Livingstone. 3. Drug Discovery and Clinical Research by SK Gupta. JAYPEE Publication. 4. Basic Principles of Clinical Research Methodology by SK Gupta. JAYPEE Publication 5. B.G. Katzung, Basic and Clinical Pharmacology, Lange Medical Publications, 1998. 6. Drug Receptors & their Effectors; edited by Nigel, J.M. Birdsall, MC Millan Publishers

Ltd. 7. Text Book of Receptor Pharmacology - John C. Foreman, Torben Johansen

PHARMACOLOGICAL SCREENING METHODS &TOXICOLOGY (Paper code: MPCL203)

1. Laboratory Animals

a) CPCSEA guidelines to conduct experiments on animals and Good laboratory practices.

b) Commonly used laboratory, transgenic and other genetically prone animal models (viz., nude mice, SH rats, etc.).

c) Techniques of blood collection, anaesthesia and euthanasia of experimental animals. d) Methods of biological assay, principles of biological assays with certain examples

mentioned in monograph. 2. Screening for the pharmacological activity using animal models

i. Drugs used for Cardiovascular System– Anti-hypertensives, anti-arrythmics, vasodilators and diuretics.

ii. Drugs used for Central Nervous System (CNS) – behavioural and muscle co-ordination, CNS stimulants and depressants, anxiolytics, anti-epileptics and Nootropics.

iii. Drugs used for neurodegenerative diseases like Parkinsonism, Alzheimers iv. Drugs used for Respiratory System – Anti- asthmatics, COPD, Anti- allergic. v. Drugs used for Reproductive System –Anti-fertility agents.

vi. Analgesics, anti-inflammatory and antipyretic agents. vii. Drugs used for Gastrointestinal System – Anti-ulcer, anti-emetic, anti-diarrhoeal.

viii. Drugs used for metabolic disorders like anti-diabetic, anti-hyperlipidemic, antiobesity, and hepatoprotective agents.

3. Toxicology i. Physicochemical, Biochemical and genetic basis of toxicity, principles of

toxicokinectics, mutagenesis and carcinogenesis. ii. Acute, sub-acute and chronic toxicity studies according to OECD guidelines.


1. Herbal Drug Technology 2nd Edition by S S Agrawal, M Paridhavi. Orient Black Swan Pvt. Ltd. for Pharmacological Screening Methods.

2. Drug Screening Methods by SK Gupta, 3rd Edition, JAYPEE Publication 3. R.K.Goyal. Practicals in Pharmacology: B.S. Shah Prakashan, Ahmedabad. 4. Drug discovery and Evaluation by Vogel H.G. 5. Screening Methods in Pharmacology by P. Turner, Vol. I & II, Academic Press, New

York & London. 6. Fundamentals of Experimental Pharmacology by M.N. Ghosh, Scientific Book

Agency, Calcutta. 7. Handbook of Experimental Pharmacology by S.K.Kulkarni, Vallabh Prakashan, Delhi. 8. Molecular Pharmacology: From DNA to Drug Discovery. John Dickenson et.al 9. Basic Cell Culture protocols by Cheril D.Helgason and Cindy L.Miller

PHARMACOLOGICAL SCREENING METHODS & TOXICOLOGY PRACTICAL

(Paper code: MPCL203P)

i. Biological standardization of drugs like Histamine, Acetylcholine, 5-HT. ii. Experiments for studying the effects of the more important biogenic agents like

histamine, acetylcholine, 5HT, oxytocin and their effect in the presence of antagonist on suitable isolated tissue preparations.

iii. Estimation of PA2 values of various antagonists under suitable isolated tissue preparations.

iv. Experiments on CVS- Invasive and non-invasive measurement of rat BP, Effect of various drugs on isolated heart preparations on various animal models under normal, arrhythmic and hypodynamic conditions.

v. Monitoring of drug concentration in saliva/urine /blood. Text and References:

1. Herbal Drug Technology 2nd Edition by S S Agrawal, M Paridhavi. Orient Black Swan Pvt. Ltd. for Pharmacological Screening Methods.

2. Drug Screening Methods by SK Gupta, 3rd Edition, JAYPEE Publication 3. R.K.Goyal. Practicals in Pharmacology: B.S. Shah Prakashan, Ahmedabad. 4. Handbook of experimental pharmacology by S.K.Kulkarni. 5. Screening methods in Pharmacology by Robert Turner, A. 6. Drug Discovery and Evaluation by Vogel HG. 7. The Pharmacological basis of therapeutics – Goodman and Gilman’s. 8. Fundamentals of experimental pharmacology by M.N.Ghosh.

SYLLABUS FOR M. PHARM. PHARMACEUTICS M. Pharm.- Ist Semester

PRODUCT DEVELOPMENT

Paper code: MPCU102

1. Preformulation Studies: pka and solubility kinetics, pH profile, partition coefficient, crystal morphology, polymorphism, powder flow, surface characteristics, dissolution, compatibility studies, protocol for preformulation studies. Solubilisation Techniques: Determination of solubility, solubility parameter, methods of solubilisation including addition of cosolvent, surface active agents, complexation, dielectric constant, hydrotrophy chemical modification. Drug stability: solution stability, solid state stability, parameters for physical stability testing, accelerated stability and self life assignment of drugs and Pharmaceuticals. 2. Dosage form technology and Process Validation: Tablet technology-Formulation, manufacturing and evaluation with special emphasis to unit processes involved including mixing, drying, size reduction, granulation technology, compression and compression coating. Coating of solid dosage form: Aqueous and onaqueouscoating, polymers, process controls, coating equipments, coating pans Accela coata Bi-coater, Driacoater, fluid bed coating equipment e.g. Glatt & Kugel coate, Application and metering equipment, particle coating methods, pelletisation. Liquid dosage forms: formulation, solubilisation and evaluation of liquid dosage forms including suspensions and emulsions. Processing and equipment used in manufacture. Capsule formulation: a. Hard gelatin capsules : Manufacturing process and material used in the shell Different materials used for automatic filling based on auger, vibratory and piston tamp fill (Dosing Disk and Dosator Machines) principles..b: Soft getain capsule 3. Parentral Technology: Formulation stabilization and manufacture of small and large volume parentrals, stabilization evaluation and quality control, Environmental controls and design considerations for parentral production facility, freeze drying. 4. Stability: Theoretical consideration, Derivative pathways, stability indicating assays, Influences of packaging components on dosage form stability, Stabilization of Pharmaceutical. ICH and WHO stability guidelines 5. Dissolution Technology: Dissolution testing devices viz. forced convection on-sink devices continues flow through methods, effect of environmental factors during dissolution testing. In Vitro-In Vivo correlations. 6. Introduction to Process Validation for oral drug delivery system

Text & References:

1. The process of new drug discovery and development. I and II Edition (2006) by Charles G. Smith, James T and O. Donnell. CRC Press, Group of Taylor and Francis.

2. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B. Schwartz, 2nd Edn. (1989) Marcel Dekker Inc. New York.

3. Pharmaceutical product development. Vandana V. Patrevale. John I. Disouza. Maharukh T.Rustomji. CRC Press, Group of Taylor and Francis.

4. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack Publishing company, Eastern Pennsylvania.

5. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial Pharmacy. Marcel Dekker Inc. New York.

6. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition. Bhalani publishing house Mumbai.

7. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, 3rd Edn, Lea & Febriger, Philadelphia.

8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn.(1995)OO2C Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.

9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied Pharmacy’ by D. A Sawant, Pragathi Books Pvt. Ltd.

PRODUCT DEVELOPMENT PRACTICAL

Paper code: MPCU102P

List of experiments

1. Preparation and evaluation of solid dispersions

2. Accelerated stability testing of Aspirin Tablets

3. Stability evaluation of Aspirin at various pH and temperature conditions

4. Generation of dissolution profiles of few dosage forms and application of the data into

various kinetic equations. Calculation of Hixon-crowell dissolution rate constant

5. Preparation and dissolution study of paracetmol tablets and comparison with the

marketed product.

6. Study of solubility and dissolution for few drugs and their respective salts.

7. Study of drug release from commercial suspension and emulsion dosage forms

8. Assignment of numerical problems, one compartment and two compartment

disposition, method of residuals, AUC and evaluation of pharmacokinetic parameters.

9. Formulation and evaluation of sustained release oral matrix tablet

10. Study of in-vitro dissolution of various SR products in market

11. Formulation and evaluation of transdermal films

12. Formulation and evaluation mucoadhesive system

13. Dissolution studies of drug in three different bio relevant dissolution media

BIO-PHARMACEUTICS AND PHARMACOKINETICS

Paper code: MPCU103

1. Drug Absorption Distribution & Disposition: Definition, structure of cell

membrane and composition, Gastrointestinal absorption- mechanism, factors affecting

drug absorption: Biological, Physiological, Physico-chemical and Pharmaceutical

dosage form factors; Methods of determining absorption: In vivo methods;

Absorption of drugs from non-oral route. Definition, Distribution in blood and other

fluids: cellular distribution, drug penetration to CNS, placental transfer of drug and

blood flow: Volume of distribution, Plasma protein binding: Drug distribution and

drug effects, Drug binding in issues.

2. Pharmacokinetics. Open one compartment, two compartment & three compartment

models& their limitations. Non-compartmental pharmacokinetics. Graphical methods

of calculating pharmacokinetic parameters. Kinetic of multiple dosing:- loading and

maintenance doses, kinetics of reversible pharmacological effects – direct and indirect

effects. Mean Residence Time (MRT), Statistical Moments Theory, Mean Absorption

Time (MAT), Mean Dissolution Time (MDT).

3. Non- Linear Pharmacokinetics: Recognition of non- linearity, one and two

compartment open model with Michaelis- Menton kinetics, determination of Km and

Vm non linear tissue binding constants.

4. Bioavailability and Bioequivalence: Definition, study design for the assessment of

bioavailability and bioequivalence, bio-equivalence with reference to BCS. Factors

influencing bioavailability and bioequivalence. Correlation of in vitro dissolution & in

vivo bioavailability.

Text & Reference:

1. Gibaldi M., Pharmacokinetics, Marcel Dekker Inc. New York.

2. Abdou, H.M. Dissolution, Bioavailability and Bioequivalence Mack Publishing Co.

3. Easton, PA

4. Smith, R.V. & Stewart, J.T. Textbook of Biopharmaceutical Analysis Lea and

Febiger, Philadelphia.

5. Wagner J.G.- Fundamentals of Clinical Pharmacokinetics, Drug Intelligence Pub.

6. Hamilton.

7. Welling P.G. Tse , F.I.S & Dighe, S.V.(eds), Pharmaceutical Bioequivalence, Marcel

8. Dekker Inc.. New York.

9. Gibalidi, M., Perrier, D Pharmacokinetics Marcel Dekker Inc. New York

10. Rowland, M.& Tozer T.N., Clinical Pharmacokinetics- Concept and Application, Lea

and Fegiber USA.

M. Pharm.- IInd Semester

INDUSTRIAL PHARMACY & PRACTICES

Paper code: MPCU202

A. Technology Transfer: Pilot plant scale up studies and its significance, Key elements of technology transfer, Technology transfer documentation.

B. Validation: ICH & WHO guidelines, validation of manufacturing facilities, I.Q./O.Q. and certification, Process validation strategies.

C. Good Manufacturing Practices: GMP in manufacturing, Processing, Packaging and holding of drugs; Production and process controls, Inspection for compliance with GMP: Premises, design, construction, maintenance, equipment, warehousing, ISO9000 certification

D. Packaging and labelling controls: New concepts in Pharmaceuticals packaging, package design research, evaluation of Packaging and labelling material, regulatory guidelines for packaging and labelling, labelling operations and drug product inspection for solid, liquid and sterile dosage forms.

E. Optimization: Optimization techniques and its application in pharmaceutical formulations and processing.

Text & Reference:

1. Theory and Practice of Industrial Pharmacy by Lachmann Liebermann. 2. Modern Pharmaceutics; By Gilbert and S. Banker. 3. Remington’s Pharmaceutical Sciences. 4. Advances in Pharmaceutical Sciences Vol. 1-5 ; By Bean & A.H. Beckett. 5. Bentley’s Textbook of Pharmaceutics – Rawlins. 6. Good manufacturing practices for Pharmaceuticals : A plan for total quality control, 7. Second edition By Sidney H. Willing. 8. Ross, Packaging of Pharmaceuticals 9. Lachman L, Lieberman H.A. & Kanig J.L. The Theory & Practice of Industrial 10. Pharmacy. ‘Varghese Publishing Home. 11. Levin M.A. Pharmaceutics process Scale up Marcel Dekker New York 12. DeSpatuz.J.F. ‘Automation and Validation of Information in Pharmaceutical

processing Marcel Dekker, New York.

ADVANCES IN DRUG DELIVERY SYSTEM

Paper code: MPCU203

A. Oral Controlled Release Drug Delivery: Osmotic, membrane-permeation; pH-control; ion-exchange controlled, controlled gel diffusion; hydrodynamic pressure controlled systems, matrix systems, floating systems

B. Novel Drug Delivery System: Applications of novel drug delivery carriers in drug

targeting, Approaches used for brain targeting, Liposomes, niosomes, dendrimers, microspheres and nanoparticles.

C. Transdermal Drugs Delivery System: Structure and function of skin, Factors

influencing transdermal delivery, permeation enhancers. Formulation & evaluation of transdermal drug delivery system, Iontophoresis and sonophoresis

D. Pulmonary Drug Delivery Systems: Characteristics and challenges in pulmonary

drug delivery, Assessment of Pulmonary Drug Absorption, Current technologies in pulmonary drug delivery devices, Nebulizers, Metered dose inhalers, Dry powder inhalers

E. Ophthalmic Drug Delivery System: Conventional and advanced ophthalmic dosage

forms, Approaches for efficient ocular drug delivery: inserts and implants

F. Biotechnology: Monoclonal antibody and their role in drug targeting, protein and peptide delivery, Recombinant DNA technology, Gene therapy: approaches used, safety and ethical considerations of biologicals.

Text & Reference:

1. Chien YQ., ‘Novel Drug Delivery Systems-Fundamentals, Developmental concepts.’Biomedical Assessment, Marcel Dekker, New York.

2. Chien YW.,ed., ‘Transdermal Controlled Systemic Medications’Marcel Dekker, New York.

3. Jain N. K., ‘ Pharmaceutical Product development’ CBS Publishers & Distributors, New Delhi.

4. Banker GS & Rhodes C.T. ,’Modern Pharmaceutics’, Marcel Dekker, New York. 5. Lachman L, Lieberman B.A. & KanigIL.’ The Theory & Practice of Industrial Ph-2,

Tmacy’, Varghese Publishing Home. 6. Aulton M.E., ‘Pharmaceutics- The Science of Dosage form Design’ Churchill

Livingstone. 7. Potts R.O. & Guy R.H., ‘Mechanism of Trans Dermal Drug Delivery’, Mercel

Dekker, New York.

ADVANCES IN DRUG DELIVERY SYSTEM PRACTICAL

Paper code: MPCU203P

Syllabus: Practicals as per theory syllabus of Advances in Drug Delivery System.

1. To prepare and evaluate floating tablets of given drug.

2. To prepare and evaluate of sustained release matrix tablets of given drug.

3. To prepare and evaluate hydrogels

4. To prepare and evaluate the transdermal patch of given drug.

5. Formulation and evaluation of mucoadhesive buccal patches of given drug.

6. To prepare and characterize the liposomes of given drug.

7. To prepare microemulsion of given poorly soluble drug

8. To prepare and characterize the niosomes of given drug.

9. To prepare and characterize the micropheres of various polymers.

10. To prepare and characterize the polymeric nanoparticles of given drug.

11. To prepare and characterize the solid lipid nanoparticles of given drug.

SYLLABUS FOR M. PHARM PHARMACEUTICAL CHEMISTRY M. Pharm. Ist Semester

PHARMACEUTICAL CHEMISTRY-I

(Advanced Organic Chemistry-I) Paper code: MPCH102

(A) Basic principles of organic chemistry will be dealt at the advanced level including the

following: localised and delocalised bonding, various intermediatory species in organic chemistry like carbocations, carboanions, free radicals, carbenes and nitrenes, various types of mechanisms and their methods of determination.

(B) Selected examples from the following types of reaction will be covered : Aliphatic and Aromatic nucleophilic substitution reactions, Electrophilic substitution reactions, Elimination and rearrangement reactions, Free radical substitution, Addition to carbon-carbon and carbon-heteroatom multiple bonds, and oxidation – reduction reactions.

(C) General methods of synthesis and applications of drugs of five, six membered and fused heterocylces such as imidazole, pyrazole, triazole, pyrimidine, quinoline, phenothiazine and purine. Synthesis of few representative drugs containing these heterocyclic nucleus.

(D) Study of mechanism and synthetic applications of following named reactions: Ugi reaction, Brook rearrangement, Ullmann coupling reactions, Dieckmann reaction, Doebner-Miller Reaction, Sandmeyer Reaction, Mitsunobu reaction, Mannich reaction, Vilsmeyer-Haack Reaction, Sharpless asymmetric epoxidation, Baeyer-Villiger oxidation, Shapiro & Suzuki reaction, Ozonolysis and Michael addition reaction

Text & References:

1. Advanced Organic Chemistry — Reactions, Mechanisms & Structure, Jerry March 2. Organic Chemistry — Vol I to III, S.P. Mukherji, S.P.Singh and R.S.Kapoor 3. Reaction Mechanisms in Organic Chemistry, S.M. Mukherjee and S.P.Singh 4. A Guide Book to Mechanisms in Organic Chemistry, Peter Sykes 5. Stereochemistry of Carbon Compounds, Eliel 6. Structure and Mechanism in Organic Chemistry, C.K.Ingold 7. Organic Chemistry — Vols I & II, I.L. Finar 8. Molecular Reactions and Photochemistry, C.H.Depny and O.L.Chapman 9. Physical Organic Chemistry, Jack Hyne 10. Organic Chemistry, Morrison & Boyd 11. Experimental Methods in Organic Chemistry, Moore and Dalrymple 12. Organic Chemistry-Solomons G. and Fryhle C., Wiley, New York 13. Organic Chemistry-Mc Murry J., Books/Cole, Pacific Grove (USA) 14. Synthon approach –Stuart Warren 15. Organic Chemistry- Pine, Hendrickson 16. Technique of Organic Chemistry, E. Weisberger

Pharmaceutical Chemistry Practical -I

Paper code: MPCH102P

A. Purification of organic solvents and separation of binary mixtures. B. To perform the following reactions of synthetic importance

1. Claisen-schimidt reaction. 2. Benzilic acid rearrangement. 3. Beckmann rearrangement. 4. Hoffmann rearrangement 5. Mannich reaction

C. Synthesis of organic compounds by adapting different approaches involving (3 experiments) a. Oxidation b. Reduction/hydrogenation c. Nitration

D. To carry out the preparation of following organic compounds 1. Preparation of 4-chlorobenzhydrylpiperazine (an intermediate for cetirizine HCl). 2. Preparation of 4-iodotoluene from p-toluidine. 3. NaBH4 reduction of vanillin to vanillyl alcohol 4. Preparation of umbelliferone by Pechhman reaction 5. Preparation of triphenyl imidazole

Pharmaceutical Chemistry-II

(Advanced Medicinal Chemistry) Paper code: MPCH103

(A) Systematic study, SAR, Mechanism of action and synthesis of new generation molecules

of following class of drugs: Anti-hypertensive drugs, Psychoactive drugs, Anticonvulsant drugs, H1 & H2 receptor antagonist, NSAIDs, COX-1 & COX-2 inhibitors, Opiate analgesics, Adrenergic & Cholinergic agents, Antifertility, Antineoplastic and Antiviral agents.

(B) Recombinant DNA technology: rDNA technology, hybridoma technology, New

pharmaceuticals derived from biotechnology; Oligonucleotide therapy. Gene therapy: Introduction, Clinical application and recent advances in gene therapy, principles of RNA & DNA estimation.

(C) Steroids- General introduction, chemistry of sterols, sapogenin and cardiac glycosides. Stereochemistry and nomenclature of steroids, Structure elucidation of male & female sex hormones (testosterone, Estradial, progesterone), Adrenocortcoids (carsisone) and contraceptive agents.

(D) Free Radical Generation in body, its importance, capture mechanism, free radical

inhibition and its importance, Metabolic changes of xenobiotics in the body. Autocoids: Chemistry of prostaglandins, leukotrienes and thromboxanes.

(E) Study of active constituent of crude drugs used in Indigenous system: Diabetic therapy – Gymnema sylvestre, Salacia reticulate, Pterocarpus marsupiam, Swertia chirata, Trigonella foenum graccum; Liver dysfunction – Phyllanthus niruri; Antitumor – Curcuma longa Linn.

Text & References:

1. Medicinal Chemistry — A Biochemical Approach, Thomas Nogrady. 2. Essentials of Medicinal Chemistry, Andrujus , Korolkovas. 3. Medicinal Chemistry, A. Burger Vols. I to V 4. Drug Synthesis, Lednicer and Mischler Vols. I to V 5. Principles of Medicinal Chemistry, W. O. Foye 6. Medicinal Chemistry : Principles & Practice, F.D. King 7. Organic Photochemistry, J.M. Coxon and B. Halton 8. Phytochemistry Vol. I and II by Miller, Jan Nostrant Rein Hld. 9. Recent advances in Phytochemistry Vol. I to IV – Scikel Runeckles. 10. Chemistry of natural products Vol I onwards IWPAC. 11. Natural Product Chemistry Nakanishi Gggolo.


Pharmaceutical Chemistry-III (Advanced Organic Chemistry-II)

Paper code: MPCH202

(A) Green Chemistry

i. Introduction, principles of green chemistry.

ii. Microwave assisted reactions: merit and demerits of its use, increased reaction rates,

mechanism, superheating effects of microwave, effects of solvents in microwave

assisted synthesis, microwave technology in process optimization, its applications in

various organic reactions and heterocycles synthesis.

(B) Photochemical Reactions: Basic principles, Photo-oxidation, photo-addition and photo-

fragmentation reactions with examples.

Pericyclic reactions: Mechanism, types of pericyclic reactions such as cyclo addition,

elctrocyclic reaction and sigmatropic rearrangement reactions with examples.

(C) Catalysis:

i. Types of catalysis and their advantages and disadvantages. Heterogeneous catalysis –

preparation, characterization, kinetics, supported catalysts, catalyst deactivation and

regeneration, some examples of heterogeneous catalysis used in synthesis of drugs.

Homogenous catalysis, hydrogenation, hydroformylation, hydrocyanation, Wilkinson

catalysts, chiral ligands and chiral induction, Ziegler‐Natta catalysts, some examples

of homogenous catalysis used in synthesis of drugs

ii. Biocatalysis: use of enzymes in organic synthesis, immobilized enzymes/cells in

organic reaction. Phase transfer catalysis ‐ theory and applications

(D) Stereochemistry & Asymmetric Synthesis

i. Basic concepts in stereochemistry – optical activity, specific rotation, racemates and

resolution of racemates, the Cahn, Ingold, Prelog (CIP) sequence rule, meso

compounds, pseudo asymmetric centres, axes of symmetry, Fischers D and L

notation, cis-trans isomerism, E and Z notation.

ii. Methods of asymmetric synthesis using chiral pool, chiral auxiliaries and catalytic

asymmetric synthesis, enantiopure and stereo selective synthesis with examples.

Text & References:

1. “Advanced Organic chemistry, Reaction, mechanisms and structure”, J March, John

Wiley and sons, New York.

2. “Mechanism and structure in organic chemistry”, ES Gould, Hold Rinchart and

Winston, NewYork.

3. “Organic Chemistry” Clayden, Greeves, Warren and Woihers., Oxford University

Press 2001.

4. “Organic Chemistry” Vol I and II. I.L. Finar. ELBS, 6th edition, 1995.

5. Carey, Organic chemistry, 5th edition (Viva Books Pvt. Ltd.)

6. Organic synthesis-the disconnection approach, S. Warren, Wily India

7. Principles of organic synthesis, ROCNorman and JMCoxan, Nelson thorns

8. Organic synthesis- Special techniques VK Ahluwalia and R Aggarwal, Narosa

Publishers

9. Organic reaction mechanisms 4th edition, VK Ahluwalia and RK Parashar, Narosa

Publishers

Pharmaceutical Chemistry-IV (Drug Designing and Medicinal Chemistry)

Paper code: MPCH203

(A) Drug Design: Approaches to drug design, method of variation, biochemical and

physiological approaches. Lead compound - Search & Optimization : Search of lead

compound from natural products and other sources, selection of test compounds. Methods

of lead optimization – synthesis of analogs, variation of substituents, extension of

structure, ring versus chain structures, ring contraction and expansion. Case study of

Cimitidine and pantaprazole. Isosterism & bioisosterism- Concepts of isosterism in drug

design; Classical and non classical isosterism, Application of bioisosterism.

(B) Basic concept of Prodrug, Carrier linked prodrugs/ Bioprecursors, Design of prodrugs

of different functional group, Prodrugs to improve patient acceptability, Drug solubility,

Drug absorption and distribution, site specific drug delivery and sustained drug action etc.

(C) Analog Design: Analogue based drug discovery – Analogues as means of discovering

new drugs, Drug likeliness and Analogue based drug discovery, Privileged Structures and

Analogue-Based Drug Discovery.

(D) Enzyme inhibitors: Enzyme kinetics & types of Enzyme inhibitors, Enzyme inhibitors in

medicine. Competitive, non-competitive, allosteric and suicide inhibitors, Design of

various enzyme inhibitors with special reference to ACE inhibitors, sulphonamides,

statins etc.

(E) Quantitative structure activity relationship (QSAR): Physicochemical parameters –

hydrophobicity, electronic and steric parameters, Hansch analysis – Steps involved, Facts

to be considered, Development of one-target and multi-target QSAR models in case of

antimicrobial agents, Free-Wilson analysis, Craig plot and Topliss scheme, Simplex

method, 3D-QSAR approaches like Docking and CoMFA.

(F) Peptidomimetics: Therapeutic values of Peptidomimetics. Use of peptidomimetics in

drug design, cyclisation of peptides, constrained amino acids, amide bond isosteres, and

oligonucleotide therapeutics.

(G) Combinatorial chemistry and High throughput screening: Different techniques, Solid

phase synthesis, Solution phase synthesis, Parallel synthesis, applications of

combinatorial chemistry. Deconvolution techniques and applications of combinatorial

chemistry. High Throughput Screening- general outline, importance and application.

(H) The Protein Data Bank (PDB) and the Nucleic Acid Data Bank (NDB). The PDB and the

mm CIF file formats for the storage and dissemination of molecular structures. Concept

of free energy of molecules. Introduction to various force fields and their relative merits

and demerits. Techniques for Molecular energy minimization, Monte Carlo and

Molecular Dynamics simulation.

Text & References: 1. Strategy of Drug Design, Brucell 2. Principles of Drug Design, Smith 3. The Organic Chemistry of the Drug Design and Drug Action, Richard B. Silverman 4. Drug Design — Vol. I to XV, Ariens 5. Chemical and Physical Approaches to Rational Drug Design, David B. Weiner &

William V. Williamms 6. Medicinal Chemistry - A Biochemical Approach, Thomas Nogrady. 7. Essentials of Medicinal Chemistry, Andrujus, Korolkovas. 8. Medicinal Chemistry, A. Burger Vols. I to V 9. Drug Synthesis, Lednicer and Mischler Vols. I to V 10. Principles of Medicinal Chemistry, W. O. Foye 11. Comprehensive Medicinal Chemistry, C. Hansch et. al. 12. Theoretical Drug Design Methods, R. Franke 13. The Organic Chemistry of the Drug Design and Drug Action, Richard B. Silverman 14. Combinatorial Chemistry — Synthesis and Applications, Stephen R. Wilson and

Anthony W. Czarnik

Pharmaceutical Chemistry Practical -II

Paper code: MPCH 203P

1. Synthesis of medicinally important compounds involving more than one step along with purification and characterization using TLC, melting point and IR spectroscopy.

2. Comparative study of synthesis of APIs/intermediates by different synthetic routes and assignments on regulatory requirements in API.

3. To perform the experiments involving green chemistry and microwave irradiated reactions of synthetic importance.

4. Experiments related to drug design i. 2D-QSAR based experiments

ii. 3D-QSAR based experiments iii. Docking study and Virtual screening based experiment

SYLLABUS FOR M. PHARM PHARMACOGNOSY & PHYTOCHEMISTRY


PHARMACOGNOSY & PHYTOCHEMISTRY-I (ADVANCES IN PHARMACOGNOSY & PHYTOCHEMISTRY)

Paper code: MPCG 102

1. Industrially important volatile oils: Natural occurrence, their chemistry & trade.

2. Application of UV, IR, NMR, 1HNMR, 13CNMR & Mass spectroscopy for structural elucidation of phytosterols, flavonoids & terpenoids.

3. Comparative Phytochemistry: phytochemical classification of plants, relationship between Phytochemistry and taxonomy, novel and unpredicted compounds.

4. Plant Tissue Culture: History, principle of plant tissue culture (PTC), types of media, types of cultures and techniques: Callus culture, Suspension cultures, Meristem culture, Protoplast cultures, Haploid cultures, immobilization, organogenesis, embryogenesis, micro- propagation.

5. Application of plant tissue culture in Pharmacognosy/production of phytopharmaceuticals.

6. Recent advances in the field of Pharmacognosy & phytochemistry with special reference to anticancer, antidiabetic, anti-inflammatory agent, immunomodulators, hepatoprotective, memory enhancers.

Text & References:

1. Pharmacognosy, Trease & Evans 15th and 16th edition, Saunders Company, London 2. Chemical Plant Taxonomy, Swain T. (1963) Academic Press London. 3. Cultivation and Utilization of medicinal plants by C.K. Atal, R.R. L. Jammu. 4. Plant Cell and Tissue Culture, Street H.E. (1997), Blackwell Scientific, London. 5. Plant Cell and Tissue Culture Narayanaswamy S. (1997), Madras Science Foundation,

Madras. 6. “Biotechnology in Agriculture and Forestry-volume 4, 7, 8, 9, 15 (1988-91), Springer-

Verlag, Berlin. 7. Natural Products of Plants by Kaufmann, CRC Press New York.

8. Chemistry of Natural Products, Nakanishi K(1977), Kodansha Book Publishing Company,Osaka (Japan).

9. Phytochemistry and Plant Cultivation, Vol. 2, Mohd. Ali (2008), CBS Publishers, New Delhi, Bangalore.

10. Techniques in Terpenoid Identification, Mohd. Ali (2001), Birla Publications (Regd.) Shahdara, Delhi.

11. Introduction to Plant Tissue Culture by M.K Razdan & S.S. Bhojwani,vol-5,1st edition, Elsevier publication

12. Fitoterapia (last ten years). 13. Planta medica (last ten years). 14. Plant cell, Tissue and Organ Culture (last ten years). 15. Journal of Ethnopharmacology (last ten years). 16. Journal of Natural Products (last ten years). 17. Phytochemistry (last ten years). 18. MAPA, NISCAIR (last ten years). 19. Martin Dean F, Gorge Padilla, Marine Pharmacognosy.

PHARMACOGNOSY & PHYTOCHEMISTRY-I (ADVANCES IN PHARMACOGNOSY & PHYTOCHEMISTRY) PRACTICALS

Paper code: MPCG102P

1. Study of the Soxhlet apparatus. 2. Study of the Clavenger apparatus used to determine the volatile oils in drugs. 3. Preparation of the thin layer chromatographic plates. 4. Extraction of volatile oil from eucalyptus leaves and to perform the TLC of extracted

oil. 5. Extraction of volatile oil from lemongrass leaves and to perform the TLC of extracted

oil. 6. Extraction of volatile oil from umbelliferous drug and to perform the TLC of

extracted oil. 7. Extraction of starch from potato. 8. Isolation of curcumin from the powdered turmeric. 9. Estimation of the total phenolic contents in given churna. 10. Identification of plant constituents with techniques viz. Thin Layer

chromatography, Preparative TLC, Paper chromatography, HPLC or UV.

PHARMACOGONOSY & PHYTOCHEMISTRY-II (MEDICINAL PLANT CULTIVATION)

Paper code: MPCG103

1. Introduction: Medicinal plant based industry, Export and import of plants,

threatened/endangered plants, geographical variation of plant variety.

2. Insect and disease management of medicinal and aromatic plants: Integrated pest management, Plant-based insecticides, microbial phytotoxins as herbicides.

3. Factors affecting cultivation and utilization of various methods applied in cultivation technology. Profile of some high trade value plant: Giloy, Gudmar, Isabgol, Kalmegh, Mulethi, Sarpagandha and Tulsi.

4. Transgenic plants: Approaches for production of transgenic plant and application.

5. Enzymes of plant origin: Types, properties, isolation, purification, application, and tests for enzymes.

6. Marine Pharmacognosy: Definition, present status, study of important bioactive agents, chemistry and uses. Text & References:

1. Advanced Methods in Plant Breeding and Biotechnology by David R Murray, CAB

International Panima Book Distributors, 1991.

2. Plant Tissue Culture by Dixon, IRL Press Oxford Washington DC,1985

3. Plant Chromosome Analysis, Manipulation and Engineering by Arun and Archna

Sharma,1st edition,Harwood academic Publishers,1999.

4. Comprehensive Biotechnology by Murray Moo-Young,Volume I-IV,Pergamon Press

Ltd.,1985.

5. Transgenic Plants by R Ranjan, Agrobotanica, 1999.

6. Cultivation and Utilization of Medicinal and Aromatic Plants, Atal CK and Kapur

BM, RRL, Jammu

7. Biotechnology,S.S. Kori,2nd edition 2005,Vallabh Prakashan

8. Pharmacogonosy, Trease & Evans 15th and 16th edition, Saunders Company,London


PHARMACOGNOSY AND PHYTOCHEMISTRY-III

(STANDARDIZATION OF NATURAL PRODUCTS AND FORMULATIONS)

Paper code: MPCG202

Factor affecting quality of crude drugs, preservation of crude drugs, detection of common adulterants, microbial contamination, toxic metals, pesticides, insecticides and insect infestation in whole and powdered drugs.

2. Standardization requirement of herbal medicine, their quality, safety and efficacy assessment.

3. Importance of monographs of medicinal plants, their comparative study as per IP, API, BHP, WHO monographs/guidelines for medicinal products.

4. Quality control of plant drugs and herbal formulations by use HPTLC and HPLC finger-printing; GC and other chromatographic techniques.

5. Markers, sources of markers, choice of active/ analytical markers, Marker analysis.

6. General principles of formulations including physico-chemical properties like Ph, solubility, distribution coefficient, etc.; preparation of single and multi-component formulation of different dosage forms.

Text & References:

1. Quality Control of Herbal Drugs by Pulok K. Mukherjee, 1st edition, Business Horizons Publishers, New Delhi. 2. Indian Herbal Pharmacopoeia, Vol. 1 & 2, RRL, IDMA, 1998, 2000. 3. Indian Pharmacopoeia, 2014, Published by IPC, Ghaziabad. 4. Ayurvedic Pharmacopoeia, Vol. 1-7. 5. Plant drug analysis, 2nd edition by Wagner , Bladt . 6. Pharmacognosy, Trease and Evans, (2009) 16th edition, Saunders and Co., London. 7. Standardization of Botanicals by V Rajpal, Vol-I Eastern Publishers, New Delhi, 2002.

PHARMACOGNOSY AND PHYTOCHEMISTRY-IV

(NUTRACEUTICALS, HERBAL COSMETICS & PHYTOCHEMICAL TECHNIQUES) Paper code: MPCG203

1. Herbal Nutraceuticals: Different types of additives - Edible dyes, plant sweetener and

perfumes, dietary antioxidants. 2. Scope, historical background and present status of herbal cosmetics technology. The

sources and description of raw materials of herbal origin like fixed oils, waxes, gums, colours, perfumes, protective agents, bleaching agents, preservatives.

3. Study of ingredients used in various Herbal cosmetic products such as creams,

powders, lotions, hair products, lipsticks, with suitable formulation.

4. Different extraction methods including advanced extraction techniques like supercritical fluid extraction, microwave-assisted extraction, ultrasound assisted extraction, solid-phase micro-extraction including headspace technique.

5. Isolation techniques: Fractionation and solvent partitioning. Chromatography: General

principles and separation mechanisms, classification, normal and reversed phase, bonded phase. Chromatographic separations including column chromatography, vacuum liquid chromatography, flash chromatography (medium pressure liquid chromatography), preparative TLC & HPLC. Purification techniques for isolated phytoconstituents.

6. High Throughput Screening (HTS) in herbal drugs.

Text & References:

1. Natural Products Isolation, Humana press, Totowa, New Jersey, Cannell RJP. Ed. Latest Edition.

2. Modern Separation methods. Natural products reports (1991). Vol. 8, 391-413. Marston A and Hostettmann K.

3. Pharmacognosy, Trease & Evans 15th and 16th edition, Saunders Company, London 4. Quality Control of Herbal Drugs, Pulok K. Mukherjee 1st edition 5. Dosage form Design, Javed Ali ,1st edition 6. H. Pande, The complete technology book on herbal perfumes and cosmetic”, National

institute of industrial Research, Delhi 7. Henry cosmetology-Martin M. Rieger 8. Herbal cosmetics, Beauty through herbs-Dr Urjita Jain 9. Natural Products Isolation, Humana press, Totowa, New Jersey, Cannell RJP. Ed.

Latest Edition.

10. Modern Separation methods. Natural products reports (1991). Vol. 8, 391-413. Marston A and Hostettmann K.

11. Pharmacognosy, Trease & Evans 15th and 16th edition, Saunders Company, London 12. Quality Control of Herbal Drugs, Pulok K. Mukherjee 1st edition 13. Dosage form Design, Javed Ali ,1st edition 14. H. Pande, The complete technology book on herbal perfumes and cosmetic”, National

institute of industrial Research, Delhi 15. Henry cosmetology-Martin M. Rieger 16. Herbal cosmetics, Beauty through herbs-Dr Urjita Jain

PHARMACOGNOSY AND PHYTOCHEMISTRY-IV

(NUTRACEUTICALS, COSMETICS AND HERBAL TOXICITY) PRACTICAL

Paper code: MPCG203P

1. Isolation of Hesperidin from Orange peel. 2. Isolation of Piperine from Piper nigrum. 3. Isolation of Sennosides from Senna leaves. 4. Isolation of Caffeine from Tea leaves. 5. Isolation of pectin from Citrus peels or Apple. 6. Extraction of volatile oil from Umbelliferous fruit and to perform the TLC of extracted

oil. 7. Extraction of volatile oil from Ginger and to perform the TLC of extracted oil. 8. Quantitative estimation of some above isolated phytochemicals by UV or HPLC or

HPTLC method. 9. Standardization of some herbal drugs (studied in theory). 10. Preparation of a herbal cosmetic.

SYLLABUS FOR M. PHARM. QUALITY ASSURANCE

M.Pharm. Ist Semester

QUALITY MANAGEMENT Paper code: MPQA102

1. Pharmaceutical quality Management: Basics of Quality Management, Total

Quality Management (TQM), Principles of Six sigma, ISO 9001:2008, 9001:2015, ISO

14001:2004, Pharmaceutical Quality Management – ICH Q10, Knowledgemanagement, Quality Metrics, Operational Excellence and Quality ManagementReview. OSHA’s guidelines, NABL certification and accreditation, CFR-21 part 11, WHOGMP requirements. 2. Quality Systems: Introduction to Six Sigma Model for Quality Management,

Manufacture and control on dosage forms, manufacturing documents -Master formula. Batch formula records, Standard Operating Procedures-a model SOP.Quality audit of manufacturing processes and facilities. Change Management/ Change control. Basic concept of measurement of uncertainty, Out of Specifications (OOS), Out of Trend (OOT)in drug analysis andcorrective action, Complaints- evaluation and handling, Investigation and determination of root cause, Corrective & Preventive Actions (CAPA), Product Returns and Recalls, Vendor Qualification, Annual Product Reviews, Batch Review and Batch Release area, clearance/ Line clearance.

3. Quality Control & Quality Assurance:Concept and evolution and scopes of Quality Control and QualityAssurance,Good Laboratory Practice, GMP, Overview of ICH Guidelines - QSEM, with specialemphasis on Q-series guidelines.Good Laboratory Practices: Scope of GLP, Quality Control laboratory- responsibilities, GLP routine controls, instruments reagents, sampling plans, standard test procedures.Quality assurance unit,protocol for conduct of non clinical testing, control on animal house, report preparationand documentation. CPCSEA guidelines.

4. cGMP guidelines according to schedule M, USFDA (inclusive of CDER andCBER) Pharmaceutical Inspection Convention(PIC), WHO and EMEA covering:Organization and personnel responsibilities, training, hygiene and personal records,drug industry location, design, construction and plant lay out, maintenance, sanitation,environmental control, utilities and maintenance of sterile areas, control ofcontamination and Good Warehousing Practice.

5. Analysis of raw materials, finished products, packaging materials, in processquality control (IPQC), developing specification (ICH Q6 and Q3): purchasespecifications and maintenance of stores for raw materials.In process quality control and finished products quality control for following dosageforms in Pharma industry according to Indian, US and British pharmacopoeias:tablets, capsules,ointments, suppositories, creams, parenterals, ophthalmic andsurgical products (How torefer pharmacopoeias)

Reference Books:

1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3rdrevised edition, Volume I & II, Mumbai, 1996.

2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69, MarcelDekkerSeries, 1995.

3. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and relatedmaterials Vol I & II, 2nd edition, WHO Publications, 1999.

4. ICH guidelines 5. ISO 9000 and total quality management 6. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000. 7. Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and

TheirSuppliers, Sixth Edition, (Volume 1 - With Checklists and Software Package). TaylorFrancis; 2003.

8. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley &Sons;2008.

9. The Quality Management Sourcebook: An International Guide to Materials and resources By Christine Avery; Diane Zabel, Routledge, 1997

10. Good Manufacturing-Practices for Pharmaceuticals, by Graham Bunn and Joseph 6th Ed. D.Nally (Dec 26, 2006)

11. Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results, ByAl Endres, Wiley, 2000

12. Organizing for High Performance: Employee Involvement, TQM, Reengineering, andKnowledge Management in the Fortune 1000: The CEO Report By Edward E. Lawler;Susan Albers Mohrman; George Benson, Jossey-Bass, 2001

13. Corporate Culture and the Quality Organization By James W. Fairfield-Sonn, QuorumBooks, 2001

14. The Quality Management Sourcebook: An International Guide to Materials andResources By Christine Avery; Diane Zabel, Routledge, 1997

15. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications 16. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo,

ASQPublications

QUALITY ASSURANCE PRACTICAL

Paper code: MPQA102P 1. Analysis of pharmacopoeial compounds in bulk and in their formulations (tablet/capsules/ semisolids) by UV Vis spectrophotometer 2. Analytical Method Validation of simultaneous estimation of multi-drug component containing formulations by UV spectrophotometry 3. Case studies on

- Total Quality Management - Six Sigma - Change Management/ Change control. Deviations, - Out of Specifications (OOS) - Out of Trend (OOT) - Corrective & Preventive Actions (CAPA)

4. Development of Stability study protocol 5. In process and finished product quality control tests for tablets, capsules, parenterals and semisolid dosage forms. 6. To carry out pre formulation study for tablets, parenterals. 7. To study the effect of pH on the solubility of drugs 8. Quality control tests for Primary and secondary packaging materials 9. Calibration and Validation of UV-Vis Spectrophotometer 10. Calibration and Validation of General Laboratory Equipments.

PRODUCT DEVELOPMENT Paper code: MPQA103

1. Preformulation Studies: pka and solubility kinetics, pH profile, partition coefficient, crystal morphology, polymorphism, powder flow, surface characteristics, dissolution, compatibility studies, protocol for preformulation studies. Solubilisation Techniques: Determination of solubility, solubility parameter, methods of solubilisation including addition of cosolvent, surface active agents, complexation, dielectric constant, hydrotrophy chemical modification. Drug stability: solution stability, solid state stability, parameters for physical stability testing, accelerated stability and self-life assignment of drugs and Pharmaceuticals. 2. Dosage form technology and Process Validation: Tablet technology-Formulation, manufacturing and evaluation with special emphasis to unit processes involved including mixing, drying, size reduction, granulation technology, compression and compression coating. Coating of solid dosage form: Aqueous and onaqueouscoating, polymers, process controls, coating equipments, coating pans Accelacoata Bi-coater, Driacoater, fluid bed coating equipment e.g. Glatt& Kugel coate, Application and metering equipment, particle coating methods, pelletisation. Liquid dosage forms: formulation, solubilisation and evaluation of liquid dosage forms including suspensions and emulsions. Processing and equipment used in manufacture. Capsule formulation: a. Hard gelatin capsules: Manufacturing process and material used in the shell Different materials used for automatic filling based on auger, vibratory and piston tamp fill (Dosing Disk and Dosator Machines) principles..b: Soft getain capsule. 3. Parentral Technology: Formulation stabilization and manufacture of small and large volume parentrals, stabilization evaluation and quality control, Environmental controls and design considerations for parentral production facility, freeze drying. 4. Stability: Theoretical consideration, Derivative pathways, stability indicating assays, Influences of packaging components on dosage form stability, Stabilization of Pharmaceutical. ICH and WHO stability guidelines. 5. Dissolution Technology: Dissolution testing devices viz. forced convection on-sink devices continues flow through methods, effect of environmental factors during dissolution testing. In Vitro-In Vivo correlations. 6. Introduction to Process Validation for oral drug delivery system Text & References:

1. The process of new drug discovery and development. I and II Edition (2006) by Charles G. Smith, James T and O. Donnell. CRC Press, Group of Taylor and Francis.

2. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B. Schwartz, 2nd Edn. (1989) Marcel Dekker Inc. New York.

3. Pharmaceutical product development. Vandana V. Patrevale. John I. Disouza. MaharukhT.Rustomji. CRC Press, Group of Taylor and Francis.

4. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack Publishing company, Eastern Pennsylvania.

5. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial Pharmacy. Marcel Dekker Inc. New York.

6. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition. Bhalani publishing house Mumbai.

7. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, 3rdEdn, Lea &Febriger, Philadelphia.

8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn.(1995)OO2C Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.

9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied Pharmacy’ by D. A Sawant, Pragathi Books Pvt. Ltd.

SYLLABUS-M. PHARM. QUALITY ASSURANCE IInd Semester

DOCUMENTATION AND REGULATORY WRITING

Paper code: MPQA202

1. Documentation in Pharmaceutical Industry: Overview of the various documentation such as Exploratory Product Development Brief (EPDB) for Drug substance and Drug product, Product Development Plan (PDP), Product Development Report (PDR), SOPs, Records, Protocols, Specifications, Master Formula Record, Batch Manufacturing Record and its calculations, Batch Reconciliation, Batch Packaging Records, Print pack specifications, Distribution records, Certificate of Analysis (CoA), Site Master File and Drug Master Files (DMF).

2. Dossier Preparation and Submission: Introduction and overview of dossiers, contents and organization of dossier, binders and sections, compilation and review of dossier. Paper submissions, overview and modules of CTD Electronic submission: Planning &requirements for electronic CTD submission and validating the submission.

3. Audits and Inspections: Introduction, types of audits: GMP compliance audit, Audit policy, Internal and External Audits, Second Party Audits, External third party audits. Auditing strategies, Preparation and conductance, audit analysis, report and follow up. Inspections: Pre-approval inspections, Inspection of pharmaceutical manufacturers, drug distribution channels, inspection report, Root cause analysis, Corrective and Preventive action (CAPA), Auditing/inspection of manufacturing facilities by regulatory agencies. (US/UK/EU etc)Timelines for audits/inspection.

4. Product Life Cycle Management: Lifecycle Management, FDA Inspection and Enforcement, Establishment Inspection Report (EIR), Warning Letters, Recalls, Seizure and Injunctions. Post marketing reporting requirements and post approval labeling changes.

References: 1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and Gil Bismuth,

Interpharm/CRC, Boca Raton, London New York, Washington D.C. 2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by Shayne Cox Gad.

Wiley-Interscience, A John Wiley and sons, Inc., Publications. 3. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-loana

Stefan, Jacobus F. Van Staden. Taylor and Francis (2005). 4. Understanding, Managing and Implementing Quality: Frameworks, Techniques and Cases,

By Jiju Antony; David Preece, Routledge, 2002 5. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ

Publications 6. Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke Okes, 2009,

ASQ Publications 7. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash.

8. Country specific Regulatory Guidelines (available from internet): CDSO publications and updates of drug and Cosmetics act and rules (Govt. of India); CDER Publications and Guidance; EMEA Publications and Guidance

PHARMACEUTICAL VALIDATION

Paper code: MPQA203

1. Introduction to Validation: Definition of Calibration, Qualification and Validation. Scope, frequency and importance of Validation and Qualification. Documentation and types of Process Validation (Prospective, Concurrent, Retrospective and Revalidation) and Equipment Qualification (IQ, OQ, PQ). Examples of qualification of laboratory and manufacturing equipments/instruments such as Fluid Bed and Tray dryers, Autoclaves UV-Visible spectrophotometer, FTIR, GC, HPLC, Dissolution test apparatus, Hot air oven and validation of utility systems such as Pharmaceutical water system and HVAC system

2. Analytical &Bio-analytical Method Validation: General principles, Validation of analytical and bio-analytical method asper ICH guidelines and USP.

3. Cleaning & Computer System Validation: Cleaning Method development, Validation of analytical methodused in cleaning, Cleaning of Equipment& Facilities. Validation of facilities in sterile and non-sterile plant.Computerized system validation: Electronic records and digital signature - 21 CFRPart 11 and GAMP 5.

4. Packaging material & their Validation: Types, performance, assuring quality of glass; types of plastics used, Drug plastic interactions; different types of closures and closure liners; film wrapper; blister packs; bubble packs; shrink packaging; foil / plastic pouches, bottle seals, tape seals, breakable seals and sealed tubes; quality control of packaging material and filling equipment, product package compatibility, transit worthiness of package, evaluation of stability of packaging material and integrated validation of packaging material.

5. Quality by design (QbD) & process analytical technology (PAT): What is QbD,Why QbD is required, Advantages, Elements of QbD, and Terminology: QTPP. CMA, CQA, CPP, RLD, Design space, Design of Experiments, Risk Assessment and mitigation/minimization. Quality by Design, Formulations by Design, QbD for drug products, Drug Substances, Excipients and Analytical QbD. PAT guidance, standards and regulatory requirements.

References: 1. B. T. Loftus & R. A. Nash, "Pharmaceutical Process Validation", Drugs and Pharm Sci.

Series, Vol. 129, 3rd Ed., Marcel Dekker Inc., N.Y. T 2. Theory & Practice of Industrial Pharmacy, 3rd edition, Leon Lachman, Herbert A.

Lieberman, Joseph. L. Karig, Varghese Publishing House, Bombay. 3. Validation of Aseptic Pharmaceutical Processes, 2nd Edition, by Carleton & Agalloco,

(Marcel Dekker). 4. Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance

in the Pharmaceutical, Medical Device, and Biotech Industries, Syed Imtiaz Haider 5. Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip

A.Cloud, Interpharm Press 6. Analytical Method validation and Instrument Performance Verification by Churg

Chan,Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Interscience. 7. ICH and USP guidelines for analytical and bio-analytical method validation.

QUALITY ASSURANCE PRACTICAL

Paper code: MPQA203P 1. Analysis of pharmacopoeial compounds and their formulations by UV Vis spectrophotometer 2. Experiments based on HPLC, GC 3. Calibration of glasswares&pH meter 4. Calibration of FTIR spectrophotometer 5. Calibration of GC instrument 6. Calibration of HPLC instrument 7. Cleaning validation of one equipment 8. Analytical Method Validation of given compound 9. Bio-analytical Method Validation of given compound (using any biological fluid like plasma, urine) 10. Preparation of Validation Protocol, Audit report and inspection report.

SYLLABUS FOR M. PHARM. DRUG REGULATORY AFFAIRS

IST SEMESTER

NATIONAL AND INTERNATIONAL DRUG APPROVAL REGULATIONS

Paper code: MPDR102

1. New Drug Application- Rules and Procedures in India.

Drugs and Cosmetics Act 1940 and other relevant provisions (Rules-1945, Schedules and Guidelines)for approval of Drugs, Medical Devices and Biologicals. Role & functions of Central Drug Standard Control Organization and State Licensing Authority. Rules, Regulations, Guidelines for Regulatory filing of Drugs, Medical Devices and Biologicalsto DCGI office; Format and contents of regulatory dossier filing.

2. New Drug Application- Rules and Procedures in USA. Organization structure and functions of FDA. Federal register and Code of Federal Regulations (CFR), Introduction to United States Federal, Food, Drug and Cosmetic Act (FFDCA), Hatch Waxman act and Orange book, Purple book, Drug Master Files (DMF) system in US. Regulatory Approval Process for Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Supplemental New Drug Application (SNDA); Changes to an approved NDA / ANDA. Regulatoryconsiderations for manufacturing, packaging and labeling of pharmaceuticals in USA.

3. New Drug Application- Rules and Procedures in EU. Organization and structure of EMA,General guidelines, Active Substance Master Files (ASMF) system in EU, Marketing Authorization procedures in EU (Centralized procedure,Decentralized procedure, Mutual recognition procedure and National Procedure). Regulatoryconsiderations for manufacturing, packaging and labeling of pharmaceuticals in EU.

4. New Drug Application- Rules and Procedures in Asia & South Asia. Japan: Organization of the PMDA, Pharmaceutical Laws and regulations, types of registration applications, DMF system in Japan& Asian Countries, drug regulatory approval process, Regulatory considerations for manufacturing, packaging and labeling of pharmaceuticals in Japan and Asian countries.

References: 1. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and

IsaderKaufer,Marcel Dekker series, Vol.143Pharmaceutical Regulatory Process, Edited by Ira R. Berry MarcelDekker Series,Vol.144

2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P.Martin, Drugs and the Pharmaceutical Sciences,Vol.185Informa Health care Publishers.

3. New Drug Approval Process: Accelerating Global Registrations By Richard AGuarino, MD, 5thedition, Drugs and the Pharmaceutical Sciences, Vol.190.

4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.

5. Drugs: From Discovery to Approval, Second Edition By Rick Ng 6. New Drug Development: A Regulatory Overview, Eighth Edition By Mark Mathieu 7. Pharmaceutical Risk Management By Jeffrey E. Fetterman, Wayne L. Pines and Gary

H. Slatko 8. Preparation and Maintenance of the IND Application in eCTD Format By William K.

Sietsema 9. Country Specific Guidelines from official websites

REGULATORY AFFAIRS PRACTICAL

Paper code: MPDR102P

1. Preparation of clinical trial protocol for registering trial in India 2. Registration for conducting BA/ BE studies in India 3. Labeling comparison between brand & generics. 4. Preparation of regulatory dossier as per Indian CTD format 5. Preparation of checklist for registration of IND as per ICH CTD format. 6. Preparation of checklist for registration of NDA as per ICH CTD format. 7. Preparation of checklist for registration of ANDA as per ICH CTD format. 8. Case studies on response with scientific rationale to USFDA Warning Letter 9. Preparation of regulatory submission using eCTD software 10. Comparison of Clinical Trial Application requirements of US, EU and Japan of a

dosage form. 11. Preparation of Biologics License Applications (BLA) 12. Preparation of documents required for Vaccine Product Approval 13. Checklist for CE marking for various classes of devices for EU

CLINICAL RESEARCH REGULATIONS

Paper code: MPDR103

1. Basics for Clinical Trials for Drug Development Process Phases of clinical trials, Clinical Trial protocol; Phase 0; Phase I and subtype studies; Phase II; Phase III and Phase IV studies. Ethical principles governing informed consent process; Patient Information Sheet and Informed Consent Form and documentation.

2. History and Basics of Clinical Trials (CT) Historical Perspectives: Nuremberg Code, Thalidomide study, Nazis Trials, Tuskegee SyphilisStudy, The Belmont Report, The declaration of Helsinki; Origin of International Conference on Harmonization - Good Clinical Practice (ICH-GCP)guidelines. Ethics of clinical research in special population. Institutional Review Board/Independent Ethics Committee/Ethics Committee – composition,roles, responsibilities, review and approval process and ongoing monitoring of safety data; Responsibilities of sponsor, CRO, and investigator in ethical conduct of clinical research

3. Regulations Governing Clinical Trials: India, USA & EU Schedule Y and ICMR Ethical Guidelines for Biomedical Research; CFR 21: Part 50: Protection of Human Subjects; Part 54: Financial Disclosure by Clinical Investigators; Part 312: IND Application; Part 314: Application for FDA Approval to Market a New Drug; Part 320: Bioavailability and bioequivalence requirements; Part 812: Investigational Device Exemptions; Part 822: Post-market surveillance; FDA Safety Reporting Requirements for INDs and BA/BE Studies; FDA Med Watch. EU Directives 2001; EudraLex (EMEA) Volume 3 – Scientific guidelines for medicinal products for human use; EU Annual Safety Report (ASR)

4. Clinical Research related Guidelines & Introduction to regulatory guidance on Efficacy and Safety

Good Clinical Practice Guidelines (ICH GCP E6); Indian GCP Guidelines andCDSCO guidelines for clinical trials. ICH Guidance’s: E4 – Dose Response Information to support Drug Registration; E7 – Studies in support of General Population: Geriatrics; E8 – General Considerations of Clinical Trials; E10 – Choice of Control Groups and Related Issues in Clinical Trials; E 11 – Clinical Investigation of Medicinal Products in the Pediatric Population References: 1. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay

A.Rozovsky and Rodney K. Adams 2. HIPAA and Human Subjects Research: A Question and Answer Reference Guide By Mark Barnes,

JD, LLM and Jennifer Kulynych, JD, PhD 3. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick

P. Ognibene 4. Reviewing Clinical Trials: A Guide for the Ethics Committee; Johan PE Karlberg and Marjorie A

Speers; Karlberg, Johan PetterEinar, Hong Kong. 5. International Pharmaceutical Product Registration: Aspects of Quality, Safety and Efficacy;

Anthony C. Cartwright; Taylor & Francis Inc., USA. 6. New Drug Approval Process: The Global Challenge; Guarino, Richard A; Marcel Dekker Inc., NY. 7. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics; Douglas J.

Pisano, David Mantus; CRC Press, USA 8. Country Specific Guidelines from official websites.

RECOMMENDED WEBSITES: 1. EU Clinical Research Directive 2001: http://www.eortc.be/services/doc/clinical-

eudirective-04-april-01.pdf 2. Code of Federal

Regulations,FDA:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm 3. Guidelines of International Conference on

Harmonization:http://www.ich.org/products/guidelines.html 4. Eudralex Guidelines: http://www.gmpcompliance.info/euguide.htm 5. FDA New Drug Application: 6. http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmeticActF

DCAct/FDCActChapterVDrugsandDevices/ucm108125.htm 7. Medicines and Healthcare products Regulatory Agency: http://www.mhra.gov.uk 8. Central Drugs Standard Control Organization Guidance for Industry:

http://cdsco.nic.in/CDSCOGuidanceForIndustry.pdf 9. ICMR Ethical Guidelines for Biomedical Research:

http://icmr.nic.in/ethical_guidelines.pdf

http://www.eortc.be/services/doc/clinical-eudirective-04-april-01.pdf�

http://www.eortc.be/services/doc/clinical-eudirective-04-april-01.pdf�

http://www.ich.org/products/guidelines.html�

http://www.fda.gov/regulatoryinformation/legislation/FederalFoodDrugandCosmetic�

http://www.mhra.gov.uk/�

M.Pharm. IIND SEMESTER

DOCUMENTATION AND REGULATORY WRITING

Paper code: MPDR202

1. Documentation in Pharmaceutical Industry: Overview of the various documentation such as Exploratory Product Development Brief (EPDB) for Drug substance and Drug product, Product Development Plan (PDP), Product Development Report (PDR), SOPs, Records, Protocols, Specifications, Master Formula Record, Batch Manufacturing Record and its calculations, Batch Reconciliation, Batch Packaging Records, Print pack specifications, Distribution records, Certificate of Analysis (CoA), Site Master File and Drug Master Files (DMF).

2. Dossier Preparation and Submission: Introduction and overview of dossiers, contents and organization of dossier, binders and sections, compilation and review of dossier. Paper submissions, overview and modules of CTD Electronic submission: Planning &requirements for electronic CTD submission and validating the submission.

3. Audits and Inspections: Introduction, types of audits: GMP compliance audit, Audit policy, Internal and External Audits, Second Party Audits, External third party audits. Auditing strategies, Preparation and conductance, audit analysis, report and follow up. Inspections: Pre-approval inspections, Inspection of pharmaceutical manufacturers, drug distribution channels, inspection report, Root cause analysis, Corrective and Preventive action (CAPA), Auditing/inspection of manufacturing facilities by regulatory agencies. (US/UK/EU etc)Timelines for audits/inspection.

4. Product Life Cycle Management: Lifecycle Management, FDA Inspection and Enforcement, Establishment Inspection Report (EIR), Warning Letters, Recalls, Seizure and Injunctions. Post marketing reporting requirements and post approval labeling changes.

References: 9. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and Gil Bismuth,

Interpharm/CRC, Boca Raton, London New York, Washington D.C. 10. Pharmaceutical Manufacturing Handbook, Regulations and Quality by Shayne Cox Gad.

Wiley-Interscience, A John Wiley and sons, Inc., Publications. 11. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-loana

Stefan, Jacobus F. Van Staden. Taylor and Francis (2005). 12. Understanding, Managing and Implementing Quality: Frameworks, Techniques and Cases,

By Jiju Antony; David Preece, Routledge, 2002 13. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ

Publications 14. Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke Okes, 2009,

ASQ Publications 15. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash. 16. Country specific Regulatory Guidelines (available from internet): CDSO publications and

updates of drug and Cosmetics act and rules (Govt. of India); CDER Publications and Guidance; EMEA Publications and Guidance

BIOLOGICS AND MEDICAL DEVICES REGULATIONS

Paper code: MPDR203

1. Biologics Regulations in India, USA and EU: INDIA: Introduction to biologics and their regulations, Data Requirements for Pre-clinical Studies, Clinical Trial Application, Market Authorization Application, Post-Market Data and Pharmacovigilance. USA & EU: Introduction, different biological products, regulations and guidance on biologics/ biosimilars, development and approval, pre-clinical and clinical development considerations, advertising, labelling and packing of biologics/biosimilars

2. Vaccine, Blood and Blood Products regulations in India, US and European Union: Regulatory Requirements, Clinical evaluation, Label Requirements, Marketing authorization, Registration or licensing, Quality assessment, Pharmacovigilance.

3. Introductions to Medical Devices & Their Regulations: Introduction, History of Medical Device Regulation, Classification. Global Medical Device Nomenclature (GMDN); Function and working of International Medical Device Regulators Forum (IMDRF) &Global Harmonization Task Force on Medical Devices (GHTF). Quality System Regulations and Quality Risk Management of Medical Devices: ISO 13485 and ISO 14971. Adverse Event Reporting of Medical device.

4. Medical Devices Regulations in India, USA and EU: Introduction, Classification, Regulatory approval process for Medical Devices, Pre-Market Approval (PMA), Investigational Device Exemption (IDE) and In vitro Diagnostics classification and approval process, CE certification process. Regulations in WHO.

References: 1. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and

Biologics, Douglas J. Pisano, David S. Mantus; Informa,2008 2. Biological Drug Products: Development and Strategies; Wei Wang, Manmohan

Singh; wiley,2013 3. Development of Vaccines: From Discovery to Clinical Testing; Manmohan Singh ,

Indresh K. Srivastava;Wiley, 2011 4. Medical Device Development: A Regulatory Overview by Jonathan S. Kahan 5. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

by John J. Tobin and Gary Walsh 6. Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics by

Carmen Medina Recommended Websites:

1. Country Specific Guidelines from official websites. 2. www.who.int/biologicals/en 3. www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ 4. www.ihn-org.com; www.isbtweb.org; www.cdsco.nic.in; www.ema.europa.eu 5. Guidelines on Similar Biologics: Regulatory Requirements for Marketing

Authorization in India

http://www.ihn-org.com/�

http://www.isbtweb.org/�

http://www.cdsco.nic.in/�

http://www.ema.europa.eu/�

REGULATORY AFFAIRS PRACTICAL

Paper code: MPDR203P

1. Case studies on - Change Management/ Change control. Deviations - Corrective & Preventive Actions (CAPA) 2. Preparation of audit/inspections checklist for various agencies 3. Preparation of submission to FDA using eCTD software 4. Preparation of documents required for Vaccine Product Approval 5. Preparation of Checklist for Registration of Blood and Blood Products 6. Checklists for 510k and PMA for US market 7. Checklist for CE marking for various classes of devices for EU 8. Audit Checklist for Medical Device Facility 9. Clinical Investigation Plan for Medical Devices

Syllabus for M.Pharm Clinical Research

M.Pharm 1st Semester

BASIC PRINCIPLES OF CLINICAL RESEARCH Paper Code: MPCR102

1. Drug Development and Discovery

2. Introduction to Clinical Research

3. Designing of Clinical Trials

4. Drugs and Cosmetics act

5. Schedule Y

6. ICH-GCP guidelines

7. Informed Consent process protecting subjects rights

8. Role of CRC and CRA in clinical trials

Suggested Readings:

(1) Basic Principles of Clinical Research and Methodology by SK Gupta, Jypee Brothers

Medical Publishers (P) Ltd., New Delhi

(2) Ethical and Policy Issue in Research involving Human Participants. National Bioethics

advisory commission. Bethesda, Maryland USA August 2001.

(3) The Globalization of Clinical Trials. A Growing Challenge in Protecting Human

Subjects. Janet Rehnquist, Inspector General Department of Health and Human Services,

September200l

(4) The European Agency for the Evaluation of Medical Products, ICH Topic E 6. Guideline

for Good Clinical Practice. Note for guidance On

Good Clinical Practice (CPMPACFVBII9S)

(5) A.T. Kearney. Fishing for Opportunities. Successful Clinical Trials Management. Pharma

Exec. Jun l, 2006.

PHARMACOVIGILENCE: SAFETY MONITORING OF DRUGS

Paper Code: MPCR103

Pharmacovigilance I: Introduction, Historical Perspective, Pharmacovigilance –

International Scenario, Pharmacovigilance- Indian Scenario,Role of Pharmaceutical

Industries

Pharmacovigilance II: Basic Concepts, definitions and common terminologies

objectives of Pharmacovigilance, Classifications of ADR’S, Methods of

Pharmacovigilance.Pharmacovigilance in Different Countries, Risk assessment in

pharmacovigilance, Crisis Management

Pharmacovigilance III: Adverse Event, Adverse Drug Reaction, serious adverse Event

(Seriousness and Severity, Side Effect, Spontaneous Report, SUSAR etc.), Causality

Assessment (Dechallenge, Rechallenge), Stages of Causality assessments, and Methods

for estimating the Probability of ADR (Naranjo’s scale), Post Marketing Surveillance,

Signal detection procedures, WHO UMC Monitoring Centre,

Pharmacovigilance IV: ADR Reporting Form, Clinical data Management, DSMB,

sponsor: Pharmacovigilence Responsibility of the Stakeholders

Pharmacovigilence V: Pharmacovigilence Program of India (PvPI), Its aims and

objectives and its functioning, Indian Regulatory requirements as per amended schedule

Y.

Suggested Readings:

(1) Text book of Pharmacovigilance by S.K Gupta Jaypee Brothers Medical Publishers

Pvt. Ltd.

(2) WHO. The importance of Pharmacovigilance, safety monitoring of medical product.

WHO Geneva, 2002

(3) WHO. A short history of involvement in drug safety monitoring by WHO. The

importance of pharmacovigilance: Safety monitoring of medicinal products. WHO

Geneva, 2002.

(4) http://www.ich.org (accessed on January 2008)

(5) Pharmacovigilance Program of India www.ipc.gov.in/PvPI/pv_home.html

http://www.ich.org/�

http://www.ipc.gov.in/PvPI/pv_home.html�

PHARMACOVIGILENCE: SAFETY MONITORING OF DRUGS PRACTICAL

Paper Code: MPCR103P

Preparation of report on Suspected Adverse Drug Reaction on PvPIpattern :- What to report?,

Where to report?.

1. Reporting form forADR from CONSUMER as prescribed by PvPI.

2. A case report on a suspected ADR in a patient who is hospitalised.

3. Prepare a Dosiere for reporting Post Marketing Survillance of a new drug to DCGI.

4. How will you analyse the probability of suspected ADR

Suggested Readings:

(1) Text book of Pharmacovigilance by S.K Gupta Jaypee Brothers Medical Publishers

Pvt. Ltd.

(2) WHO. The importance of Pharmacovigilance, safety monitoring of medical product.

WHO Geneva, 2002

(3) WHO. A short history of involvement in drug safety monitoring by WHO. The

importance of pharmacovigilance: Safety monitoring of medicinal products. WHO

Geneva, 2002.

(4) http://www.ich.org (accessed on January 2008)

(5) Pharmacovigilance Program of India www.ipc.gov.in/PvPI/pv_home.html

http://www.ich.org/�

http://www.ipc.gov.in/PvPI/pv_home.html�

Syllabus for M.Pharm Clinical Research

M.Pharm 2nd Semester

PHARMACOECONOMICS AND OUTCOMES RESEARCH Paper code: MPCR202

Pharmacoeconomics: Principles, methods and Applications

Principle of Pharmacoeconomics, Definitions, Perspectives, Costs, Methods of

Pharmacoeconomics, Humanistic Evaluation Methods, Applications of Pharmacoeconomics,

and Clinical Pharmacy service Evaluation, Strategies to incorporate Pharmacoeconomics into

pharmacotherapy, Use the Pharmacoeconomics literature, Controversies with

Pharmacoeconomics Literature, Conduct a Pharmacoeconomics Evaluation.

Health Technology assessment

Definition, Importance of health Technology assessment (HTA), HTA Process in Different

countries.

Role of Systematic review and Meta-analysis in Evidence Based medicines

Objectives of Systematic review, Role, Rationale for doing a Meta-Analysis, Stages or

Phases of Meta-Analysis, Essential Features of systematic Review and Meta-Analysis,

Significance of Systematic Reviews and Meta- Analysis, Methods to write a systematic

review, Merits and De-merits of Systematic Reviews and Meta – analysis.

Suggested Readings:

(1) Moher1*, Larissa Shamseer1, Mike Clarke2, Davina Ghersi3, Alessandro Liberatiˆ,

Mark Petticrew4,Paul Shekelle5, Lesley A Stewart6 and PRISMA-P Group; Moher et

al.: Preferred reporting items for systematic review and meta-analysis protocols

(PRISMA-P) 2015 statement. Systematic Reviews 2015 4:1

(2) SUNY Downstate EBM Tutorial; available at

(3) A K Akobeng; Understanding systematic reviews and meta-analysis; Community

child health, public health, and epidemiology; Arch Dis Child 2005;90:845-848

http://library.downstate.edu/EBM2/research.htm

(4) Petticrew, M., & Roberts, H. (2006). Systematic reviews in the social sciences: A

practical guide. Malden, MA: Blackwell Publishing Co.

http://library.downstate.edu/EBM2/research.htm�

(5) Pippa Hemingway, Nic Brereton; What is a Systematic review?; Evidence-based

medicine; Second edition; Supported by sanofi-aventis; Available at

http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/syst-review.pdf

(6) Lindsay S. Uman; Systematic Reviews and Meta-Analyses; J Can Acad Child

Adolesc Psychiatry, 20:1, February 2011; 57-59

http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/syst-review.pdf�

CLINICAL RESEARCH METHODOLOGY Paper code: MPCR203

1. Protocol Designing

2. Sponsor’s Investigator’s Responsibilities

3. Patient Recruitment and Retention in Clinical Trials

4. Project Management in Clinical Trials

5. Role of Contract Research Organization in Clinical Research

6. Biostatistics in Clinical Trials

7. Bioequivalence Studies in Drug Development

8. Clinical Data Management

9. Introduction and history of Bioethics, ICMR and CDSCO guidelines for Bioethics,

Ethics committee role and responsibilities

Suggested Readings:

(1) Drug discovery and clinical research by SK Gupta, Jypee Brothers Medical Publishers (P)

ltd. New Delhi.

(2) 45 US Department of health and Human Services. Protection of Human subjects. Code of

Federal regulations. Title 45, Part 46, sub part D. Washington, DC:US Department of

Health and Human Services, (revised Jan 2009.

(3) The Belmont Report. Ethical Principles and Guidelines for the Protection of Human

Subjects of research. Available at:http://www.nmmu.ac.za/documents/

rcd/The%20Belmont%20 report.Pdf(1979). (accessed: November 2009).

(4) Indian council of Medical research. Ethical guidelines for biomedical research on Human

Participants.2008,27-9.

http://www.nmmu.ac.za/documents/%20rcd/The%20Belmont%20%20report.Pdf�



CLINICAL RESEARCH METHODOLOGY PRACTICAL

Paper Code: MPCR203P

1. Design a protocol for a new drug to be submitted to DCGI (NDA).

2. Design ICF for conducting Clinical Trial of a new drug.

3. Prepare SOP’s for an IRB.

4. Prepare a document for compensation for an SAE during Clinical trial.

5. Design Constitution of IRB based on CDSCO guidelines for Institution.

Suggested Readings:

(1) Drug discovery and clinical research by SK Gupta, Jypee Brothers Medical Publishers

(P) ltd. New Delhi.

(2) 45 US Department of health and Human Services. Protection of Human subjects.

Code of Federal regulations. Title 45, Part 46, sub part D. Washington, DC:US

Department of Health and Human Services, (revised Jan 2009.

(3) The Belmont Report. Ethical Principles and Guidelines for the Protection of Human

Subjects of research. Available at:http://www.nmmu.ac.za/documents/

rcd/The%20Belmont%20 report.Pdf(1979). (accessed: November 2009).

(4) Indian council of Medical research. Ethical guidelines for biomedical research on

Human Participants.2008,27-9.




Documents

DELHI PHARMACUTICAL SCIENCES & RESEARCH UNIVERSITY Govt ...dpsru.edu.in/.../bootstrap/files/M.Pharm-All-Sem-Syllabus-new.pdf · DELHI PHARMACUTICAL SCIENCES & RESEARCH UNIVERSITY