CV from pilot study or reported literature [Power / Sample Size]

posted by Karmegams  – India, 2011-06-16 06:53 (5491 d 11:23 ago) – Posting: # 7132
Views: 6,343

Dear Sir,

The intra-subject CV from pilot study or reported literature is used in sample size calculation for bioequivalence study.

The intra-subject CV is due to drug and formulation. So, is it appropriate to use CV-intra from literature of other’s product (others’ formulation) for sample size calculation?


Regards
Skar

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