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Home » GUIDANCE OFFERS TIPS ON BA, BE TESTING SAMPLES
GUIDANCE OFFERS TIPS ON BA, BE TESTING SAMPLES
July 28, 2004
The FDA, citing past lapses in the rules governing drug testing samples, 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.