Multiple dose design Sample size [Power / Sample Size]

posted by dshah – India, 2020-10-20 06:43 (46 d 00:18 ago) – Posting: # 22033
Views: 316

Dear Researcher 101,

If you have performed any single dose study, its best to perform Superposition as per SmPC/ PI instruction. Then perform the stat at Steady state- you will know the %CV for all the required parameter and then take a call.
Mostly- based on theoretical assumption, the %CV will come less in multi dose for this phenomena.
Regards,
DShah

Complete thread:

Activity
 Admin contact
21,240 posts in 4,431 threads, 1,482 registered users;
online 3 (0 registered, 3 guests [including 1 identified bots]).
Forum time: Saturday 06:01 CET (Europe/Vienna)

I believe there is no philosophical high-road in science,
with epistemological signposts. No, we are in a jungle
and find our way by trial and error,
building our road behind us as we proceed.    Max Born

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