Bioequivalence and Bioavailability Forum • 0.0501 not acceptable

0.0501 not acceptable [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2016-06-02 15:30 (3670 d 05:18 ago) – Posting: # 16379
Views: 11,816

Hi David,

welcome to the forum!

❝ Nice one Helmut, never heard!

From Stephen’s Statistical Issues in Drug Development, p.457.

I fully agree with your point of view.

❝ So it will be a matter of time until Stephen's definition will be outdated

I’m not sure if I’ll live long enough. What is the average age of members of the EMA’s Biostatistical Working Party? A member of the PKWP officially asked the BWSP whether a TIE of 0.0501 [sic] is acceptable and the answer was “No!”…

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Helmut Schütz

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Complete thread:

The EMA’s BSWP’s opinon Helmut 2016-03-04 15:37 [Two-Stage / GS Designs]
- The EMA’s BSWP’s opinon ElMaestro 2016-03-04 23:16
  - Control of the TIE (empiric via simulations vs. proof) Helmut 2016-03-05 15:17
    - To whom it may concern ElMaestro 2016-03-06 22:59
      - To whom it may concern d_labes 2016-03-07 11:41
- Opinon? d_labes 2016-03-06 13:31
  - Obsession? Helmut 2016-03-06 14:45
    - Obsession? DavidManteigas 2016-06-02 12:57
      - 0.0501 not acceptableHelmut 2016-06-02 13:30
        
        OT: Guernsey McPearson's Drug Development Dictionary d_labes 2016-06-02 14:44
        
        OT: Comparison Helmut 2016-06-02 15:59
        
        OT: Comparison d_labes 2016-06-02 16:42