2 Groups model FDA [Two-Stage / GS Designs]

posted by hiren379 – India, 2013-08-22 14:32 (2548 d 01:44 ago) – Posting: # 11336
Views: 34,547

Hi HS

» Followed by:
» If the Group-by-treatment interaction test is not statistically significant (p ≥0.1), only the Group-by-treatment term can be dropped from the model.
» … provided that the group meets minimum requirements for a complete bioequivalence study.

According to the above statement, what should be the minimum requirements of the group for a complete bioequivalence study?

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