PHEN-601NOTES

POLICIES AND REFERENCES

Dr. W. Bruce EckmanWBE Consulting,Inc

INSTRUCTOR EMAIL:beckman@torcon.com

(do not use njit email address)

With All Due Respect and Thanks To Professors

Joseph Manfredi and Marc Bernhardt

for the use of many of these slides.

COURSE DESCRIPTIONFROM THE NJIT eCATALOG

“This course provides an overview of the pharmaceutical industry, including basic information about drug discovery and development, FDA requirements and approval processes, drug dosage forms, and the role of key operational units in drug manufacturing processes. This course enables the students to: understand the role of the pharmaceutical industry in the global market and its implications; learn the fundamentals of the drug development cycle and the investment required to bring a drug to market; learn the most important drug manufacturing processes and the key elements of dosage formulation.”

CLASS NOTES

THE COURSE NOTES CAN BE FOUND AT:

will be emailed( unless limited by size)

CLASS NOTES

READ

THE

SUPPLEMENTARY

READINGS !!!

ATTENDANCE

EVEN THOUGH ATTENDANCE AND CLASS PARTICIPATION ARE NOT MANDATORY, THEY MAY BE USED AS POSITIVE FACTORS WHEN ASSIGNING FINAL GRADES.

PhEn601

• INSTRUCTOR’S TELEPHONE: 732-704-9800 x226• INSTRUCTOR’S E-MAIL ADDRESS:

beckman@torcon.com DO NOT USE NJIT EMAIL ADDRES • INSTRUCTOR’S OFFICE HOURS: OFFICE HOURS ARE

BEFORE EACH CLASS BY APPOINTMENT. • STUDENTS MAY EMAIL AT ANY TIME OR PHONE DURING

REGULAR BUSINESS HOURS. RESPONSES WILL BE HANDLED AS QUICKLY AS POSSIBLE, SUBJECT TO SCHEDULING, TRAVEL AND OTHER PRIOR COMMITMENTS. PHONE CALLS SHOULD BE LIMITED TO EMERGENCIES ONLY.

• COURSE DAY AND TIME: TUESDAY 6:00 – 9:05 P.M.

HOUSEKEEPING

• WE WILL BE USING YOUR EMAIL ADDRESS AS GIVEN TO ME TONIGHT AS NEEDED TO COMMUNICATE WITH THE CLASS. CHECK THIS REGULARLY.

• GUEST LECTURERS WILL BE SCHEDULED AS AVAILABLE AND THE CLASS SCHEDULE ADJUSTED ACCORDINGLY.

• OBTAIN AND BEGIN READING TEXT (CORRECT EDITION).

• 30 MINUTE POLICY FOR INSTRUCTOR ABSENCE • CLASS BREAKS WILL BE DISCUSSED AND A

FORMAT SELECTED, HOWEVER THIS WILL REMAIN AT THE INSTRUCTOR’S DISCRETION.

GRADESGrading Policy:• Midterm exam 35%• Final exam 35%• Quiz 1 15% • Quiz 2 15%

Important Note:The average of the midterm and the final exam grades must be >70% in order to receive a passing grade for the course.

GRADES

COURSE FINAL GRADE:

A TENTATIVE GUIDELINE FOR THE ASSIGNMENT OF FINAL GRADES IS PROVIDED BELOW:

GRADES

• The grade of “D” is not assigned to students taking graduate courses.

• Please remember that this is only a guideline designed to help the students understand how they are performing in the course.

GRADES

• Make-up exams will only be given to students who cannot attend the regular exam time, and only under documented and extraordinary circumstances. In any case, no student will be allowed to a take a make-up exam unless he/she has the prior consent of the instructor.

• If a student fails to take a quiz or an exam as scheduled, the grade will automatically be zero.

EXAMS

• A CALENDAR OF THE EXAMS IS INCLUDED IN THESE NOTES.

• ALL EXAMS ARE TYPICALLY 3 HOURS LONG, UNLESS OTHERWISE STATED.

• ALL EXAMS ARE OPEN BOOK AND OPEN NOTES, UNLESS OTHERWISE ANNOUNCED.

• THE FINAL EXAM WILL INCLUDE ALL MATERIAL COVERED THROUGHOUT THE COURSE (ALTHOUGH THE MAIN EMPHASIS OF THE EXAM MAY BE ON THE MATERIAL COVERED AFTER THE MIDTERM EXAM).

QUIZZES• A CALENDAR OF THE QUIZZES IS INCLUDED

IN THE COURSE OUTLINE BELOW.• QUIZZES ARE TYPICALLY 1 HOUR LONG

UNLESS OTHERWISE STATED.• QUIZZES MAY BE OPEN OR CLOSED BOOK

AND NOTES. FORMAT WILL BE ANNOUNCED.• QUIZZES WILL TYPICALLY COVER MATERIAL

FROM IMMEDIATELY PRECEDING CLASSES.

QUIZZES• MAKE-UP QUIZZES WILL ONLY BE GIVEN IF

APPROVED IN ADVANCE FOR DOCUMENTED AND EXTRAORDINARY CIRCUMSTANCES.

• CLASS ATTENDANCE: AS FOR ALL GRADUATE COURSES AT NJIT, ATTENDANCE IS NOT MANDATORY, BUT STRONGLY RECOMMENDED. EXPERIENCE SHOWS THAT STUDENTS WHO DO NOT REGULARLY ATTEND CLASS TYPICALLY PERFORM POORLY IN THE COURSE. IN ADDITION, DISCUSSIONS AND MATERIAL PROVIDED BY GUEST LECTURERS WILL NOT BE COVERED IN THE NOTES. IN ANY CASE, STUDENTS ARE RESPONSIBLE FOR ALL MATERIAL COVERED IN CLASS.

Check the NJIT Calendar for Important Dates!

www.njit.edu/registrar

SYLLABUS

THE FOLLOWING PAGES CONTAIN A TENTATIVE SYLLABUS.

CHANGES MAY OCCUR AND WILL BE ANNOUNCED IN CLASS.

SYLLABUS

• WK #1 SEP.6INTRODUCTION TO PhEn BY PROFESSOR ARMENANTEREMEDIES & PHARMACEUTICALS – PAST & PRESENTFOOD, DRUG & COSMETIC ACT

• WK #2 SEP.13OVERVIEW OF DRUG DISCOVERY, DEVELOPMENT,ADME, CLINICAL STUDIES

• WK #3 SEP.20FOCUS ON A DISEASEDOSAGE FORMS OVERVIEW, PREFORMULATIONSERUM CONCENTRATION,

SYLLABUS• WK #4 SEP.27

cGMP’S & CFRSOLID DOSAGE FORMS, PARTICLES & GRANULESMODIFIED/EXTENDED RELEASE, IVIVC’SQUIZ#1

• WK #5 OCT.04SEMI-SOLID PRODUCTS - OINTMENTS,CREAMS,&GELS TRANSDERMAL PRODUCTSINDUSTRY OVERVIEW PHRMA

• WK #6 OCT.11SANITARY DESIGNMATERIALS & FINISHES, EQUIPMENT DESIGNINSPECTION & QUALITY & PASSIVITY

SYLLABUS

• WK #7 OCT.18PHARMACEUTICAL WATER SYSTEMSRO, DI, DISTILLATION

• WK #8 OCT.25MIDTERM EXAMINATION

• WK #9 NOV.1SUPPOSITORIES, SOLUTIONS, VALIDATION

• WK #10 NOV.8DISPERSE SYSTEMS

• WK #11 NOV.15PARENTERALSQUIZ#2

SYLLABUS

• WK #12 NOV.22BIOLOGICALS

• WK #13 NOV.29CLEANROOMS, FACILITY DESIGN, OPTHALMICS,

RADIOPHARMACY

WK #14 DEC.6SEMESTER REVIEW/ SELECTED SPECIAL TOPICS

WK #15 DEC.20FINAL EXAM

FDA.GOV

• FDA.GOV has a wealth of information that is designed for both the general public and special groups (such as the regulated industries).

• FDA.GOV gives insights into the FDA’s current actions, priorities, and thought processes.

VAN HOUTEN LIBRARY

http://www.library.njit.edu/