Bioequivalence and Bioavailability Forum

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
Views: 578

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.

Regards,
Divyen

Complete thread:

• FDA: PD BE study balakotu 2023-07-12 04:24 [Power / Sample Size] 
  • FDA: PD BE studydshah 2023-07-13 08:45