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BIOAVAILABILITY &BIOEQUIVALENCE
LIVE Online Academy20 - 22 April 2021
COURSE OVERVIEW
Bioavailability (BA) is defined as the rate and extent to which the
unchanged active substance is absorbed and becomes available in the
systemic circulation. Understanding bioavailability is essential during
drug development as it is one of the fundamental properties of drug
formulation. Information on bioavailability is also used to determine
bioequivalence (BE) when submitting a generic dossier.
Through interactive sessions and multiple case studies this course will
evaluate every aspect of BA/BE from the regulations and types of
protocol studies to bioanalysis, statistical analysis and reporting. Once
completed you will have a solid understanding of bioavailability,
supporting you in drug development. You will also have the confidence
to develop and implement your own bioequivalence studies to ensure
speedy generic approval.
The course will also examine key aspects of biowaivers such as the
regulatory hurdles, types of biowaivers and data needed so you can
save money and time with fast biowaiver applications.
Learn how to
successfully design,
implement and report
bioavailability and
bioequivalence studies
for different formulation
types
What is bioavailability and bioequivalence?The concept of bioavailability and bioequivalenceExamining when a bioavailability or bioequivalence study is mandatoryBiowaiver: an in vivo surrogate
Introduction and definitions
MODULE ONE
Gain a critical understanding of the protocol studies used depending on thetype of drug and formulationStudy protocol: key points for single dose, steady-state, fasted and fedstudiesEstablishing methods to tackle highly variable drugs: repeated design andscale average bioequivalenceDesigning studies dependent on the type of formulation: IR, SR, DR,multiphasic, etc.Analysing the difference between an experimental and pivotal bioequivalencestudy
Evaluate the types of protocol studies used
MODULE ONE
Single doseMulti dose, steady stateFedFastedClassical cross overTwo step studiesReplicated design
Examine examples of the following Bioequivalence studies
MODULE TWO
Single doseMulti dose, steady stateFedFastedClassical cross overTwo step studiesReplicated design
Summary of Bioanalysis
MODULE TWO
Managing the sampling scheduleParameters to be submitted depending on the type of formulation and studiesSingle dose: Cmax / Tmax/AUC 0-t/ 0-72h/ 0-infinity/ partial AUCSteady state: Cmin/ fluctuation Index(FI)/ AUC/ Cmax
Pharmacokinetic parameters
MODULE THREE
Practical solutions to apply statistical analysisNumber of subjectLog transformation whyANOVA: residual variance90% confidence intervalPeriod, sequence effectRepeated designTwo step design
Statistical points and analysis
MODULE THREE
Drop out, exclusion, “Blind review”Endogenous compoundFixed dose combinationAnalysis of metabolitesComposition of mealExamining the effects of subject position: standing/lying/sittingSpecial populationStudy in non-healthy volunteersMulti-dose example
Examples of specific cases
MODULE FOUR
The extent of global harmonisationLegal requirements in specific countries and regionsData prior BE studyHow to submit a Bioequivalence studyAssessing the risk linked with BA/BE studiesDissolution data required
Regulations and requirements for a Bioequivalence study: A global perspective
MODULE FOUR
Biowaver conceptGuidance on the regulations and requirements
How to interpret the regulationsFDA vs EMA
Examining the types of BiowaiverSelf-evident BiowaversLocally Acting Locally AppliedBCS based BiowaiversStrength BiowaverIVIVC based Biowaivers
Understanding the risk when submitting a biowaiverWhat data needs to be submitted?Post approval changes
Biowaivers
MODULE FIVE
Focus on the main items to be reportedSpecial cases of Biowaiver
Reporting: Overview of key points
MODULE FIVE
Clinical Drug DevelopmentQuality AssuranceRegulatory AffairsProject ManagementBioanalyticsBiostatisticsIVIVCR&D
This course is designed for professionals working in thefollowing areas:
WHO IS THISCOURSEFOR?
For information contact our training consultants
Jessica [email protected]
+44 (0)20 7551 9521
Group bookingsReceive 10% off for 3-4 bookingsReceive 15% off for 5+ bookings