Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-16 07:23 CEST (UTC+2h)

Sample size determination for William Design [Power / Sample Size]

posted by Irene_I - Indonesia, 2018-07-04 10:27  - Posting: # 19016
Views: 258

Dear All,

I would like to ask about sample size determination for conducting William Design (3 treatment - 3 period - 6 sequence) bioequivalence. We would like to compare two test product with one reference product. Based on available literature, the drug product we would like to compare has about 19.03% intra-subject CV for AUC. Usually, we calculate the sample size by intra-subject CV from the previous study and referred to Diletti table (E Diletti, D Hauschke, and VW Steinijans, Sample size determination for bioequivalence assessment by means of confidence intervals). Is that also applicable for the 3x3x6 study? Or, is there any other method to determine sample size for william design?

I would be very thankful for your help.

Thank you very much.


Irene I

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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,527 posts in 3,938 threads, 1,190 registered users;
online 43 (0 registered, 43 guests [including 24 identified bots]).

Mankind has survived all catastrophes.
It will also survive modern medicine.    Gerhard Kocher

BEBAC Ing. Helmut Schütz