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

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)?
Where:
• α = probability of committing a type I error (i.e. rejecting the null hypothesis when it is actually true).
• β = probability of committing a type II error (i.e. failing to reject the null hypothesis when it is actually false).
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.:
• Are both drugs' expected AUC equal? i.e. E[AUC of $$\mathcal{A}$$ = E[AUC of $$\mathcal{B}$$]
• Are both drugs' expected Cmax equal? i.e. E[Cmax of $$\mathcal{A}$$ = E[Cmax of $$\mathcal{B}$$]
• Are both drugs' expected Tmax equal? i.e. E[Tmax of $$\mathcal{A}$$ = E[Tmax of $$\mathcal{B}$$]
then what is the largest α & β allowed by FDA, for each of the three hypothesis tests?

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] Ing. Helmut Schütz 