Bioequivalence and Bioavailability Forum • 2 Groups model FDA

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

posted by hiren379 – India, 2013-08-22 16:32 (4689 d 13:11 ago) – Posting: # 11336
Views: 50,983

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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