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:
[image]

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

Regards,
Divyen

Complete thread:

UA Flag
Activity
 Admin contact
22,763 posts in 4,775 threads, 1,628 registered users;
14 visitors (0 registered, 14 guests [including 2 identified bots]).
Forum time: 11:25 CEST (Europe/Vienna)

The object of statistics is information.
The objective of statistics is the understanding of information
contained in data.    Irwin and Marylees Miller

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5