Bioavailability and Bioequivalence Studies for Orally Administered Drug Products -

摘要

This guidance is intended to provide recommendations to sponsors and/orapplicants planning to include bioavailability (BA) and bioequivalence (BE) information for orally administered drug products in investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and their supplements. This guidance addresses how to meet the BA and BE requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration. The guidance is also generally applicable to non-orally administered drug products where reliance on systemic exposure measures is suitable to document BA and BE. The guidance should be useful for applicants planning to conduct BA and BE studies during the IND period for an NDA, BE studies intended for submission in an ANDA, and BE studies conducted in the postapproval period for certain changes in both NDAs and ANDAs. This guidance is designed to reduce the need for FDA drug-specific BA/BE guidances. As a result, this guidance replaces a number of previously issued FDA drug-specific BE guidances. On rare occasions, FDA may decide to provide additional BA/BE guidances for specific drug products.