FDA: PD BE study [Power / Sample Size]

posted by dshah  – India/United Kingdom, 2023-07-13 10:45 (81 d 00:40 ago) – Posting: # 23671
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Dear Kotu!

❝ Please anyone suggest me on how to calculate a Sample size for PD BE study of multiple dose, 3-way crossover (Orlistat capsule 60 mg for USA).

The recommendation is as given below:

Based on this, i assume it should be similar to BE study calculation.


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