Estimate the sample size HVD [RSABE / ABEL]

posted by Yura – Belarus, 2020-12-03 09:47 (1234 d 00:00 ago) – Posting: # 22108
Views: 2,215

Dear all
Still fashionable HVD theme, question.
Am I correct in understanding that if in the literature, for example, CV = 50% for AUC is found as the largest (for Cmax it is also more than 30%, but less than for AUC), then it will not be correct to use sampleN.scABEL to estimate the sample size? There will be no equivalence limits scaling for this parameter. And on the other hand, for the parameter Cmax there will be conditions of forced bioequivalence, since the sample size will be at least twice the allowable size calculated by the AUC parameter. How to proceed?

Regards

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,658 registered users;
108 visitors (0 registered, 108 guests [including 3 identified bots]).
Forum time: 10:48 CEST (Europe/Vienna)

The whole purpose of education is
to turn mirrors into windows.    Sydney J. Harris

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