Sample size for 3-way crossover [Power / Sample Size]

posted by chrisk – 2022-08-09 20:55 (116 d 16:26 ago) – Posting: # 23209
Views: 3,365

Dear all,

Thank you for those who created the wonderful PowerTOST package and who are sharing their knowledge in this forum.

My question relates to the sample size calculation for 3-way crossover (e.g. 3x6x3). I want to demonstrate that both test drugs T1 and T2 are BE to the reference R. The althernative hypothesis is: T1 = R and T2 = R.

When performing the sample size calculation using PowerTOST for 3-way crossover, which alternative is considered? Since there are several ways to formulate the alternatives, I wasn't sure whether the current settings of PowerTOST correspond to the one that is of my interest. If it doesn't, what is your recommendation to deal with my scenario of interest? Any reference will also be very much appreciated.

Another question is related to the number of PK parameters included. Does the sample size calculation consider the number of PK parameters for the BE?

Thank you for your help on this.

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

Complete thread:

UA Flag
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
22 visitors (0 registered, 22 guests [including 9 identified bots]).
Forum time: 12:21 CET (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

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