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Home » FDA Guidance Outlines Procedures for BA, BE Testing Samples Handling, Retention
FDA Guidance Outlines Procedures for BA, BE Testing Samples Handling, Retention
The FDA’s guidance on the quantity of bioavailability (BA) and bioequivalence (BE) testing samples to be retained by NDA applicants and contract research organizations (CRO) contains both draft and final language focusing on both the test article and reference standard.