Samples size/number of subjects [Regulatives / Guidelines]

posted by drgunasakaran1  – 2013-06-10 22:04 (4766 d 11:47 ago) – Posting: # 10767
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❝ Is there any regulations in USFDA/EMEA/ICH/ACTD regarding the number of subjects for bio-equivalence study?


Dear Jasim,

All Regulatory Guidance provided details for Sample size calculation and number of subjects required for bio-equivalence study.

For US FDA, see section sample size and drop outs

For EMA, see section 4.1.3

For ASEAN, see section 3.1 of ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence studies
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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