Sample size for Clinical endpoint BE studies [Regulatives / Guidelines]

posted by balakotu – India, 2015-08-20 11:34 (3170 d 22:25 ago) – Posting: # 15312
Views: 3,690

Dear All,

Anyone please help me on calculation of sample size for clinical endpoint bioequivalence studies.

In PK endpoint Bioequivalence studies standard parameters required for Sample sizes calculations are ratios, alpha, intra/inter CV.

What are the common parameters required for clinical endpoint bioequivalence studies (With respect to mean & proportions)?

Is there any SAS Program or any related software to construct the sample size for clinical endpoint bioequivalence studies?

Regards
Kotu

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