Bioequivalence and Bioavailability Forum • 2 Groups model FDA

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

posted by hiren379 – India, 2013-08-22 14:32 (2542 d 03:27 ago) – Posting: # 11336
Views: 34,458

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?

Complete thread:

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        2 Groups model FDAhiren379 2013-08-22 14:32
        
        Homework Helmut 2013-08-23 11:53