Bioequivalence is an important measure of in vivo drug product performance. Bioequivalence is established if the bioavailability, i.e., rate and extent of drug absorption from a test drug product does not differ significantly from the rate and extent absorption from a reference drug product. Bioequivalence applies not only to generic drug product development in an abbreviated new drug application but also to bridging studies comparing the bioavailability of a drug product used in clinical studies as part of a new drug application to the to-be-marketed brand product. After drug product approval, a bioequivalence study may be required for certain scale-up and post approval changes such as a site transfer for an extended release drug product.
The Bioequivalence focus group provides a forum to discuss the scientific issues relating to the demonstration of bioequivalence that allow for sound regulatory policy decisions. Some of the topics for discussion include the proper statistical design and metrics for bioequivalence, the determination of bioequivalence from locally acting drug products such as topical and inhalation drug products, highly variable drugs, drugs with long elimination half-lives, drugs given orally that are not systemically absorbed, and biotechnology derived drugs.
Please contact the focus group chair or AAPS if you are interested in being involved in the Bioequivalence focus group or would like more information.
Section affiliations: PPDM | RS