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 …
1 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]
2 Guidance for Industry "Handling and Retention of BA and BE Testing Samples BE/BA Inspection FDA FDA FDA Compliance Program Guidance Manual IN vivo bioequivalence 2010 BE FDA Inspection FDA FDA483 BE FDA FDA FDA BE/BA FDA FDA Regulation FDA FDA FDA 1.
3 21 CFR 2. 21 CFR 3. Final Rule [Retention of Bioavailability and bioequivalence Testing Samples] da. gov/Sc ienceResearch/SpecialTopics/RunningClini calTrials/ucm1202 4. Guidance for Industry [Handling and Retention of BA and BE Testing Samples] 5. Compliance Program Guidance Manual IN vivo bioequivalence
