Multiple dose design Sample size [Power / Sample Size]

posted by dshah  – India, 2020-10-20 08:43 (1423 d 22:44 ago) – Posting: # 22033
Views: 2,410

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:

UA Flag
Activity
 Admin contact
23,223 posts in 4,877 threads, 1,655 registered users;
26 visitors (0 registered, 26 guests [including 5 identified bots]).
Forum time: 07:27 CEST (Europe/Vienna)

One of the symptoms of an approaching nervous breakdown
is the belief that one’s work is terribly important.    Bertrand Russell

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