Multiple dose design Sample size [Power / Sample Size]

posted by dshah  – India, 2020-10-20 08:43 (1661 d 20:45 ago) – Posting: # 22033
Views: 3,306

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
23,424 posts in 4,927 threads, 1,671 registered users;
103 visitors (0 registered, 103 guests [including 6 identified bots]).
Forum time: 05:28 CEST (Europe/Vienna)

Freedom is always and exclusively
freedom for the one
who thinks differently.    Rosa Luxemburg

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