Bioavailability and Bioequivalence * *Disclaimer: The chapter reflects the views of the authors and should not be construed to represent the views or policies of the Food and Drug Administration (FDA). No official endorsement by the FDA is intended or should be inferred.

Bioavailability (BA) and bioequivalence (BE) studies are essential in oral dosage form development. This chapter provides readers an overview of general concept of BA and BE. Details on typical BA/BE study designs, study conducts, bioassays, and data analyses are discussed, with a primary focus on orally administered drugs. Special topics on BE for narrow therapeutic drugs and highly variable drugs, together with application of partial areas under the curve for BE testing are also presented. In addition, issues related to biowaiver are discussed in details.