FDA Guidance on Bioequivalence and Bioavailability Requirements for INDs and NDAs

This guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements (referred to as the NDA BA and BE Draft Guidance). This guidance contains advice on 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 may also be applicable to non-orally administered drug products when reliance on systemic exposure measures is suitable to document BA and BE (e.g., transdermal delivery systems and certain rectal and nasal drug products). The guidance should  be helpful for applicants conducting BA and BE studies during the IND period for an NDA and also for applicants conducting BE studies during the post-approval period for certain changes to drug products that are the subject of an NDA.

Read the full guidance here.