Bioequivalence and Bioavailability Forum • IBE/PBE = Two-Stage

IBE/PBE = Two-Stage [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2014-09-29 05:33 (3880 d 10:55 ago) – Posting: # 13611
Views: 12,173

Hi ElMaestro,

❝ One conclusion to draw is that the whole scaling business might not be that smart when it comes to type I errors.

Found a goody in Chow/Liu (3rd ed., but I guess you find it in the earlier ones as well). Chapter 19, Review of Regulatory Guidances on Bioequivalence, 19. Guidances on Statistical Procedures, 19.2.10 Two-Stage Test Procedure

To apply the proposed criteria for assessment of PBE or IBE, the 2001 FDA guidance suggests that a constant scale be used if the observed estimator of σ_TR or σ_WR is smaller than σ_T0 or σ_W0. However, statistically, the observed estimator of σ_TR or σ_WR being smaller than σ_T0 or σ_W0 does not mean that σ_TR or σ_WR is smaller than σ_T0 or σ_W0. A test on the null hypothesis that σ_TR or σ_WR is smaller than σ_T0 or σ_W0 is necessarily performed. As a result, the proposed statistical procedure for assessment of PBE or IBE becomes a two-stage test procedure. It is then recommended that the overall type I error rate and the calculation of power be adjusted accordingly.

PBE and IBE were never seriously implemented, but with RSABE and ABEL we face the same shyte.

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Helmut Schütz

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Complete thread:

EMA: α-inflation – the suspicion begins to mount Helmut 2014-07-21 02:04
- EMA: α-inflation – the suspicion begins to mount ElMaestro 2014-07-21 09:24
  - Why simulate a simple AB|BA at all? Helmut 2014-07-21 16:14
    - Why simulate a simple AB|BA at all? ElMaestro 2014-07-21 20:50
      - Fancy smoothing? Helmut 2014-07-21 23:13
        
        Arbitrary smoothing? d_labes 2014-07-22 08:43
        
        Noise… Helmut 2014-07-22 13:31
        
        TSD Japonica… d_labes 2014-07-22 16:06
        
        TSD Japonica… Helmut 2014-07-22 17:50
        
        Noise debugged d_labes 2014-07-24 13:47
        
        Noise debugged Helmut 2014-07-24 15:07
        
        Shit happens d_labes 2014-07-24 16:09
      - Commentary d_labes 2014-07-22 08:18
        
        Commentary nobody 2014-09-15 08:24
        
        Commentary Helmut 2014-09-15 10:12
      - IBE/PBE = Two-StageHelmut 2014-09-29 03:33
        
        IBE/PBE = Two-Stage ElMaestro 2014-09-29 15:16
        
        Sequential Design = Inflation likely… Helmut 2014-09-30 15:03