Non-inferiority Sample Size Estimation [Power / Sample Size]

posted by sury – India, 2019-04-16 08:44  – Posting: # 20171
Views: 179

Hii All...

Anyone know about the sample size estimation for the non inferiority clinical trials, as per the literatures and some google says to consider the NI Margin to some percentage and estimate the sample size

I have tried to do the same in FARTSSIE23 (Non-inferiority, Parallel), but in addition to that Standard deviation is necessary for the same and in SAS (PROC POWER), we need to provide the CV to estimate the sample size

Can we assume the standard deviation or we need to provide the exact Standard deviation (obtained from the literatures on the drug) ?

Dose the same criteria applicable as that of the ISCV concept for the bio equivalence studies?


Best Regards...


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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,400 posts in 4,121 threads, 1,323 registered users;
online 6 (0 registered, 6 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 21:01 CEST

Science is the great antidote to the poison
of enthusiasm and superstition.    Adam Smith

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5