N calculation for trial about PK superiority [Power / Sample Size]

posted by dshah  – India/United Kingdom, 2022-09-02 13:52 (573 d 10:20 ago) – Posting: # 23262
Views: 2,149

Hi Alex!

I am wondering why PK superiority? I am not getting if you do not prove faster onset of action with PD superiority, you can have advantage. Already the discussion for Tmax assessment (EMA PSG) is discussed in forum. Could you provide more details for not focusing on PD superiority?
Regards,
Divyen Shah

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
78 visitors (0 registered, 78 guests [including 13 identified bots]).
Forum time: 23:12 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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