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

posted by dshah  – India/United Kingdom, 2022-09-02 13:52 (92 d 23:47 ago) – Posting: # 23262
Views: 862

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?
Divyen Shah

Complete thread:

UA Flag
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
9 visitors (0 registered, 9 guests [including 7 identified bots]).
Forum time: 12:39 CET (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

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