An FDA draft guidance for establishing bioavailability/bioequivalence (BA/BE) was released in late March and is intended to replace the existing 2003 BA/BE guidance. The guidance details the methods most suitable and accurate for the determination of BA/BE, as required by FDA. An expanded section is included on in vitro studies and their applicability for different formulations. Changes also include subsections on combination drug/device products, endogenous substances, and advice on excipients that affect BA/BE.
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