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 PurnellJessica.Purnell@informa.com

+44 (0)20 7551 9521

Group bookingsReceive 10% off for 3-4 bookingsReceive 15% off for 5+ bookings