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Home » FDA GUIDANCE OFFERS TIPS ON HANDLING BA, BE TESTING SAMPLES
FDA GUIDANCE OFFERS TIPS ON HANDLING BA, BE TESTING SAMPLES
May 25, 2004
Citing past lapses in the rules governing drug testing samples, the FDA has issued a final guidance on how drugmakers and others should handle reserve testing samples used in bioavailabilty (BA) and bioequivalence (BE) studies that support new and generic drug applications.