Estimate the sample size HVD [RSABE / ABEL]

posted by Yura – Belarus, 2020-12-03 08:47 (52 d 04:20 ago) – Posting: # 22108
Views: 447

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

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