Bioequivalence and Bioavailability Forum

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, C_max, T_max) 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 C_max equal? i.e. E[C_max of \(\mathcal{A}\) = E[C_max of \(\mathcal{B}\)]
  
• Are both drugs' expected T_max equal? i.e. E[T_max of \(\mathcal{A}\) = E[T_max of \(\mathcal{B}\)]

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 :)

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