Bioequivalence and Bioavailability Forum • TIE depends on CVwR (and n)

TIE depends on CVwR (and n) [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2018-02-28 15:48 (1854 d 15:35 ago) – Posting: # 18485
Views: 9,009

Dear Pjs,

❝ […] study is passing the SCABE criteria.

If you are referring to the FDA’s RSABE approach, there is not problem with inflation of the Type I Error if (the true) CV_wR ≥30%. Only with CV_wR <30% problems might be massive (see this presentation).

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Helmut Schütz

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Complete thread:

question of adjustment Yura 2017-04-25 15:14 [RSABE / ABEL]
- TIE depends on CVwR (and n) Helmut 2017-04-26 14:17
  - TIE depends on CVwR (and n) Yura 2017-04-26 17:28
    - TIE depends on CVwR (and n) Helmut 2017-04-26 18:00
      - TIE depends on CVwR (and n) Yura 2017-04-26 18:55
        
        TIE depends on CVwR (and n) Yura 2017-04-28 11:13
        
        TIE = p(BE) at expanded limits Helmut 2017-04-28 19:16
        
        TIE = p(BE) at expanded limits Yura 2017-04-29 13:01
  - TIE depends on CVwR (and n) pjs 2018-02-28 14:33
    - TIE depends on CVwR (and n)Helmut 2018-02-28 14:48
      - TIE depends on CVwR (and n) pjs 2018-03-01 07:35
        
        Comparing methods for (S)ABE Helmut 2018-03-01 13:32
        
        Comparing methods for (S)ABE pjs 2018-03-05 14:50
        
        Simulating the Null Helmut 2018-03-05 17:40
    - Adjusting α Helmut 2018-03-07 16:21