What is the largest α (Alpha) & β (Beta) allowed by FDA? [General Sta­tis­tics]

posted by victor – Malaysia, 2019-11-16 21:57  – Posting: # 20813
Views: 3,890

(edited by victor on 2019-11-16 22:09)

Hi everyone! I'm new to pharmacokinetics, and I'm wondering what is the largest α (Alpha) & β (Beta) allowed by FDA, for each of the three hypothesis tests illustrated below (with each α & β highlighted with red borders)?
To elaborate, if I want to test if the population distribution of an innovator drug (denoted \(\mathcal{A}\)) estimated by random-sampling 12 healthy people, is identical to the population distribution of a generic drug (denoted \(\mathcal{B}\)), by comparing 12 sample statistics (AUC, Cmax, Tmax) of \(\mathcal{A}\) against \(\mathcal{B}\), via three hypothesis tests that determine if there are any differences in the population means of those three statistics; i.e.:
then what is the largest α & β allowed by FDA, for each of the three hypothesis tests?

Thanks in advance
P.S. if you spot any mistake in my illustration below, could you kindly inform me as well? ଘ(੭*ˊᵕˋ)੭* ̀ˋ


P.S. The following post didn't submit correctly, even though the preview for it was working. So, I decided to screenshot my question instead. Hope it is acceptable :)

Edit: Category changed; see also this post #1. Link to 643KiB 2,000px photo deleted and changed to a downscaled variant. [Helmut]

Complete thread:

 Admin contact
20,809 posts in 4,355 threads, 1,447 registered users;
online 19 (0 registered, 19 guests [including 16 identified bots]).
Forum time: 16:25 CEST (Europe/Vienna)

Medical statistician: One who will not accept that Columbus discovered America…
because he said he was looking for India in the trial plan.    Stephen Senn

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