Transcription of Q6 BE 試験において、FDA の規制に従い実施医療機関にて 分 …
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Q6 BE FDA FDA 5 FDA FDA A6 21 CFR Part 320 BIOAVAILABILITY AND bioequivalence REQUIREMENTS BE BA FDA 3 FDA 5 BE 5 - Retention of bioavailability samples - Retention of bioequivalence samples US US Final Rule [Retention of Bioavailability and bioequivalence Testing Sample] Guidance for Industry "Handling and Retention of BA and BE Testing Samples BE/BA Inspection FDA
5. Compliance Program Guidance Manual 7348.001 “IN VIVO BIOEQUIVALENCE” http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133792.h
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