Bioequivalence and Bioavailability Forum • New paper (method D for PE 0.90)

New paper (method D for PE 0.90) [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2011-04-18 14:58 (5550 d 15:06 ago) – Posting: # 6915
Views: 31,290

Dear all,

the preprint of a new paper is available:

Montague TH, Potvin D, DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ. Additional results for 'Sequential design approaches for bioequivalence studies with crossover designs' Pharm Stat. 2011. 10.1002/pst.483

Methods B and C (α 0.0294) showed non-negligible inflation of the Type I error rate (i.e., >5.2%) for a PE of 0.90 (instead of 0.95 in the 2008 paper). Method D (α 0.028) preserves the overall α and is therefore recommended. It might be possible to adjust the α level for methods B/C as well, but this has not been evaluated yet. Also:

"[…] we have not considered cases where the desired power used in the method is anything other than 80%. Increasing the power used in the methods from 80 to 90% would be expected to have similar direction of effect as decreasing the GMR used in the methods from 0.95 to 0.90. Ongoing work is seeking to generalize the methods considered in this paper and the earlier paper."

—
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Helmut Schütz

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Complete thread:

Potvin method B subtleties d_labes 2011-01-31 14:24 [Two-Stage / GS Designs]
- Potvin method B subtleties jdetlor 2011-02-01 17:17
  - Potvin method B subtleties d_labes 2011-02-02 09:15
    - Potvin method B subtleties jdetlor 2011-02-02 16:08
      - Gould d_labes 2011-02-02 16:25
        
        Gould jdetlor 2011-02-02 17:02
- Another one ... d_labes 2011-02-07 14:32
  - Oops! Helmut 2011-02-07 15:24
    - Oops! d_labes 2011-02-07 16:29
      - Oops! Helmut 2011-02-07 16:47
        
        Oops! ElMaestro 2011-02-07 17:06
        
        Oops! Helmut 2011-02-07 17:17
        
        Oops! ElMaestro 2011-02-07 18:35
        
        Simul'ants in my pants d_labes 2011-02-08 09:07
        
        Need for speed... ElMaestro 2011-02-13 10:57
        
        Need for speed... d_labes 2011-02-15 14:06
        
        Need for speed... ElMaestro 2011-02-15 17:39
        
        Pocock alpha's d_labes 2011-02-16 09:18
        
        ElMaestro's brain ElMaestro 2011-02-16 09:32
        
        ElMaestro's brain d_labes 2011-02-16 10:05
        
        ElMaestro's brain ElMaestro 2011-02-16 12:07
        
        Numbers d_labes 2011-02-16 13:45
- Bonus counter-question ElMaestro 2011-02-07 23:44
  - Speed is the question d_labes 2011-02-08 08:36
- New paper (method D for PE 0.90)Helmut 2011-04-18 12:58
  - New paper (method D for PE 0.90) d_labes 2011-04-19 08:58
    - New paper (method D for PE 0.90) Helmut 2011-04-19 14:30
    - New paper (method D for PE 0.90) ElMaestro 2011-04-19 14:49
      - Stopping criterion # futility rule Helmut 2011-04-19 15:28