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FDA Guidance for Industry: Handling and Retention of BA and BE Testing Samples


Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,

This guidance is intended to provide recommendations for study sponsors and/or drug manufacturers, contract research organizations (CROs), site management organizations (SMOs), clinical investigators, and independent third parties regarding the procedure for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies, as required by 21 CFR 320.38 and 320.63

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