Bioequivalence and Bioavailability Forum • α 0.05

α 0.05 [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2020-06-09 12:42 (221 d 10:52 ago) – Posting: # 21518
Views: 1,844

» there is no alpha value mentioned in the reference. Would like to know, which alpha value is considered in the reference for EMA and FDA.

The paper refers to the EMA’s (ABEL) and the FDA’s (RSABE) methods. Hence, 0.05 as usual.
BTW, why don’t you use software like the [image]

-package PowerTOST? The methods are supported by the functions sampleN.scABEL() and sampleN.RSABE(). Then you are free to select any GMR and power. With due respect to the two Lászlós I hold that their number of simulations (10,000) is too small (see this post).

At the latest when you have to estimate the sample size for the FDA’s reference-scaling for NTIDs you have to use PowerTOST’s function sampleN.NTIDFDA() anyway. No tables published.

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Complete thread:

Sample Size for Replicate studies arl_stat 2020-06-09 11:41 [Power / Sample Size]
- Nominal α Helmut 2020-06-09 11:49
  - Nominal α arl_stat 2020-06-09 12:30
    - α 0.05Helmut 2020-06-09 12:42
      - α 0.05 arl_stat 2020-06-11 08:15
        
        RSABE ≠ ABE: Simulations mandatory Helmut 2020-06-11 12:26
        
        RSABE ≠ ABE: Simulations mandatory arl_stat 2020-06-29 07:05