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Current Issues and Advances in the Determination of Bioequivalence*
Tuesday, November 13
2:00 pm – 4:30 pm
Symposium
ACPE #073-999-07-575-L04
Bioequivalence is an important measure of in vivo drug product performance. Bioequivalence between two drug products is established if the drug products are pharmaceutically equivalent (or similar) and the rate and extent of drug absorption (bioavailability) from these products are substantially comparable. For many solid oral drug products, bioequivalence evaluations have been based on the standard, two-way, two-sequence, two-treatment, crossover design. This design incorporates methodologies and metrics which, despite for some modifications, have been in use for approximately 40 years. The current methods of bioequivalence testing for this class of products have remained nearly unchanged for almost 20 years. With the advent of highly variable and super variable oral drug products, locally acting drug products, drug products with extended effective half-lives, and biotechnology derived drugs, new challenges exist for bioequivalence testing. The standard two-way crossover design and standard bioequivalence metrics have many shortcomings and, in some cases, are not applicable for these products. New or alternative study designs may be needed to demonstrate scientifically that two drug products are bioequivalent. As a result, we have been forced to re-examine our methods of analysis, and even our definitions of, bioequivalence, in an attempt to develop ways to effectively and efficiently evaluate comparability between “new” and “standard” formulations of these challenging drug products. This symposium will explore a number of issues and innovations in bioequivalence evaluation. The presentations will begin with an exploration of alternative designs such as replicated, parallel and sequential methods. Advantages, disadvantages and limitations of these methods will be discussed. A brief historical overview of the 15+ year debate on how to evaluate bioequivalence of highly variable, and super variable, drugs, will follow with reference to some promising methodologies that can potentially solve many of the issues related to testing these products. The role of interim and sequential analyses will be evaluated, with particular emphasis given to producer and consumer risks. The use of population-based pharmacokinetics and its role in bioequivalence testing for those instances where more intensive sampling is either not possible, or not desired, will round out the presentations.
Moderators
Charles Bon, M.S.
Biostudy Solutions LLC
Laszlo N. Endrenyi, Ph.D.
University of Toronto
Determination of Bioequivalence of Highly Variable Drugs
Laszlo N. Endrenyi, Ph.D.
University of Toronto
Interim and Sequential Analyses
Charles Bon, Ph.D.
Biostudy Solutions LLC
Application of Population Pharmacokinetics
Murray P. Ducharme, Ph.D.
MDS Pharma Services
Alternative Designs for the Determination of Bioequivalence
Charles DiLiberti, Ph.D.
Barr Labs
*Session tentatively scheduled to be recorded.
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