Bioequivalence and Bioavailability Forum • ‘alpha’ of scaled ABE?

‘alpha’ of scaled ABE? [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2013-03-15 18:27 (4460 d 23:39 ago) – Posting: # 10203
Views: 25,644

Dear Detlew!

❝ A rather natural choice IMHO would be to calculate the power at the border(s) of the widened BE acceptance limits.

Agree.

❝ GMR=1.25 if CV<=0.3 or GMR=exp(0.8925742*CV2se(CV)) if CV>0.3 for the FDA RSABE

❝ GMR=1.25 if CV<=0.3 or GMR=exp(0.7601283*CV2se(CV)) if CV>0.3 for the EMA scABEL and cap on if CV>0.5

<nitpicking>

I would prefer a GMR of 0.80 since PowerTOST employs simulations – remember the “rounding thread”? ;-)

</nitpicking>

Which designs / sample sizes have you used? I’m struggling reproducing your numbers.

❝ Interesting! At least for me :yes: .

For me as well. I will ask the two Lászlós and maybe Panos Macheras.

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Complete thread:

‘alpha’ of scaled ABE? d_labes 2013-03-15 15:56 [RSABE / ABEL]
- ‘alpha’ of scaled ABE?Helmut 2013-03-15 17:27
  - ’alpha’ of scaled ABE: design d_labes 2013-03-16 20:10
    - N=24, 48 d_labes 2013-03-18 08:11
      - adaptive design without adjustment martin 2013-03-25 20:47
        
        α adjustment? Helmut 2013-03-26 15:21
        
        iteratively adjusted alpha martin 2013-03-26 16:19
        
        throw away our sample size tables? Helmut 2013-03-26 18:02
        
        if real martin 2013-03-26 19:44
        
        regulators don’t care? Helmut 2013-03-26 21:18
        
        adjusting α Helmut 2013-08-11 16:19
        
        missing letter apapanas 2024-10-31 06:02
        
        PowerTOST: sampleN.scABEL.ad() Helmut 2024-10-31 08:41
        
        PowerTOST: sampleN.scABEL.ad() apapanas 2024-11-08 10:48
        
        Molins et al. (2017) Helmut 2024-11-08 14:34
        
        target α in sim’s? Helmut 2013-03-27 15:38
        
        target α in sim’s? martin 2013-03-27 16:36
        
        If it is real: results Helmut 2013-03-28 23:20
        
        having alpha martin 2013-03-28 15:08
        
        fixed swr Helmut 2013-03-28 23:34
        
        fixed swr martin 2013-03-29 15:07
        
        Yes but no but yes but no but… Helmut 2013-03-29 16:10

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