Multiple dose design Sample size [Power / Sample Size]

posted by Researcher101 – Egypt, 2020-10-14 12:21 (834 d 18:51 ago) – Posting: # 21997
Views: 1,824

Dears, I just wanna know if Steadystate Cmax intrasubject variability will be considered in sample size calculations of multiple dose BE? or just Cmax of single dose?

Also is it in the safe side to estimate sample size based on Cmax single dose not multiple dose?


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,477 posts in 4,708 threads, 1,603 registered users;
18 visitors (0 registered, 18 guests [including 9 identified bots]).
Forum time: 06:12 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

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