Bioequivalence and Bioavailability Forum • Molins et al. (2017)

Molins et al. (2017) [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2024-11-08 15:34 (168 d 17:20 ago) – Posting: # 24265
Views: 2,082

Hi Antigoni,

❝ Many thanks dear Helmut!

Welcome.
See also the function sample.size.adj() in this article. It implements our method^1,2 and a more conservative one.^3,4
Of course, such a conservatism comes with a price. The sample sizes can be prohibitively large.

method CVwT CVwR Target power Sample size Achieved power EMA (2010) 0.4 0.4 0.9 42 0.90325 Labes and Schütz (2016) 0.4 0.4 0.9 44 0.90523 Molins et al. (2017) 0.4 0.4 0.9 78 0.90246 method alpha TIE EMA (2010) 0.05000 0.05572 Labes and Schütz (2016) 0.04326 0.05000 Molins et al. (2017) 0.03061 0.05000

Labes D, Schütz H. Inflation of Type I Error in the Evaluation of Scaled Average Bioequivalence, and a Method for its Control. Pharm Res. 2016: 33(11); 2805–14. doi:10.1007/s11095-016-2006-1.
Assuming that the observed \(\small{CV_\text{wR}=}\) the true \(\small{CV_\text{wR}}\).
Molins E, Cobo E, Ocaña J. Two-Stage Designs Versus European Scaled Average Designs in Bioequivalence Studies for Highly Variable Drugs: Which to Choose? Stat Med. 2017; 36(30): 4777–88. doi:10.1002/sim.7452.
Assuming the ‘worst case’ \(\small{CV_\text{wR}=30\%}\) – irrespective of the observed \(\small{CV_\text{wR}}\) because the maximum inflation of the Type I Error is always at the switching \(\small{CV_\text{wR}=30\%}\) regardless the design and sample size.

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Helmut Schütz

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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