INTRODUCTION
Bioavailability (BA) and Bioequivalence (BE) studies are required of new as well as generic drug products. BA/BE are parameters with practical and public health value for drug manufacturers, for regulatory agencies, and ultimately for patients. From a drug product performance perspective, this course provides a broad perspective on the theory and practice of BA/BE, After attending this course, participants should have the ability to plan, conduct, report and evaluate bioequivalence studies skillfully.
PROGRAM OBJECTIVES
- Conveying the knowledge necessary to design and analyse bioequivalence trials
- Enhancing the understanding of their history and place within drug development
- Reviewing recent developments and their implications
- Interpreting and discussing the statistics used
WHO SHOULD ATTEND?
- Regulatory staff in the study design, study and conduct,
- Health professionals involved in pharmacokinetic analysis,
- Health professionals involved in statistical analysis,
- Health professionals involved in reporting and evaluation of bioequivalence studies.
PROGRAM OUTLINE
- Basic pharmacokinetics principles
- Bioavailability determinants (AUCt, AUCinf, Cmax,Tmax, etc.)
- Design of both single and multiple dose studies
- Mean versus individual ratio analyses
- Confidence interval calculations
- Food and other factors affecting bioavailability
- Controlled release formulations
- Cmax – Cmin fluctuations
- Intrasubject variability
- Drug interchangeability (“prescribability” versus “switchability”)
- In vitro dissolution as a predictor of bioequivalence
- Cmax/AUC and other proposed metrics for drug absorption rate
- Instances of possible use of metabolite data
- Therapeutic equivalence
- US & European regulatory requirements
- Problem areas (e.g. highly variable drugs, nonlinearity)
- “Hands-on”exercises
- Facilities for conducting BA/BE studies
- Regulatory aspects of BE studies
- Intellectual property rights
Permintaan Brosur penawaran Training
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