AAVPT Bioequivalence Webinar
- May 24, 11 AM – 1:30 PM (Eastern Time)
- Marilyn N. Martinez, Ph.D., Senior Research Scientist
- US Food and Drug Administration, Center for Veterinary Medicine
As science progresses forward, new challenges face regulators, innovator firms, and generic drug sponsors as bioequivalence concepts are being applied to support the approval of formulation changes or new generic drug applications. Martinez and Hunter recently wrote a manuscript describing these challenges, which will soon be published in the Journal of Veterinary Pharmacology and Therapeutics.
Before we can explore alternative study designs and statistical methods for addressing these difficult situations, which will be discussed at the AAVPT Bioequivalence Workshop, we need to establish a firm foundation in the basic pharmacokinetic, biopharmaceutics and statistical foundations upon which traditional bioequivalence assessments are based. It is also important to have an understanding of how these basic principles evolved in concert with recent advancements in science and technology. With that goal in mind, this two-and-a-half hour webinar covered the following topics, which prepared the participants for an active participation in the upcoming BE Workshop:
- The history of bioequivalence assessments and methods of measuring drug exposure
- Bioavailability versus bioequivalence: what is the difference?
- The basic assumptions associated with the use of bioequivalence assessments when establishing product comparability
- The bioequivalence parameters: how to calculate, what do they mean, and what potential pitfalls need to be considered)?
- Study design considerations and their implications:
- Which dose to use and why
- Crossover vs. parallel
- When is normalization by body weight appropriate
- Subject by formulation interactions,
- Why to avoid comparisons between generic formulations
- Fed versus fasting
- The issue of “variability”
- How variability impacts bioequivalence determinations: the confidence interval approach
- Factors to consider when estimating sample size
- The importance of analytical method validation
- Why can’t we compare generic to generic? The issue of drift
- The Biopharmaceutics Classification System: definitions, applications, and interspecies extrapolation
- An introduction to in vitro dissolution testing
