Sample size and Replicated studies [Power / Sample Size]

posted by Bebac user – Egypt, 2022-03-23 10:38 (320 d 18:55 ago) – Posting: # 22860
Views: 1,711

Partially replicated study, I use this code for sample size estimation

sampleN.scABEL(CV=0.3532)

+++++++++++ scaled (widened) ABEL +++++++++++
            Sample size estimation
   (simulation based on ANOVA evaluation)
---------------------------------------------
Study design: 2x3x3 (partial replicate)
log-transformed data (multiplicative model)
1e+05 studies for each step simulated.

alpha  = 0.05, target power = 0.8
CVw(T) = 0.3532; CVw(R) = 0.3532
True ratio = 0.9
ABE limits / PE constraint = 0.8 ... 1.25
EMA regulatory settings
- CVswitch            = 0.3
- cap on scABEL if CVw(R) > 0.5
- regulatory constant = 0.76
- pe constraint applied


Sample size search
 n     power
45   0.7829
48   0.8045



But, I know that I can't use more than 40 volunteers in any BE study

In these cases, what should I do ?

Complete thread:

UA Flag
Activity
 Admin contact
22,481 posts in 4,710 threads, 1,603 registered users;
17 visitors (0 registered, 17 guests [including 10 identified bots]).
Forum time: 05:34 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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