Multiple dose design Sample size [Power / Sample Size]

posted by dshah – India, 2020-10-20 06:43 (128 d 09:00 ago) – Posting: # 22033
Views: 412

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
21,356 posts in 4,458 threads, 1,493 registered users;
online 12 (1 registered, 11 guests [including 2 identified bots]).
Forum time: Thursday 14:43 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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