Use of incomplete block design? [Power / Sample Size]

posted by Olivbood – France, 2019-05-23 20:30  – Posting: # 20298
Views: 1,007

(edited by Olivbood on 2019-05-24 07:43)

Many thanks to both of you !

I come back yet again with another question.

Since the number of treatments is relatively high, the number of blood samples drawn from each subject would be quite high and the study would be time consuming (thus subjects would be more likely to dropout).

In such a case, a balanced incomplete block design with 2 periods and 6 sequences( where each subject would take only 2 treatments) is appealing.
However, I guess going with such a design have its own disadvantages such as an increase in sample size and unbalance between the sequences would be more problematic.

Do you know if such a design is practicable and likely to be accepted by the regulatory agencies? I made some researched but did not find anything convincing.

Also, how should I proceed to power such a study, if possible using the package powerTOST? Would I be bound to perform simulations and base my sample size on expected power?

Thanks !

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,685 posts in 4,176 threads, 1,351 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 23:34 UTC

Normality is a myth; there never was, and never will be,
a normal distribution.    Roy C. Geary

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