Bioequivalence and Bioavailability Forum • Range

Range [BE/BA News]

posted by Helmut – Vienna, Austria, 2022-07-28 16:43 (1072 d 05:32 ago) – Posting: # 23186
Views: 10,976

Hi Ohlbe & all,

sorry to excavate this corpse (I submitted my comments last Sunday; 34 pages…)

❝ Are they using the word in its statistical meaning (difference between the largest and smallest values) or in its lay language meaning (limits between which something varies) ? I suspect the latter: lowest and highest observed T_max values.

Discovered another one. In the first draft (EMA/CHMP/356876/2017 of July 2017) the bizarre “Comparable median and range for T_max” was given.
Stakeholders asked for a clarification and in the comments (EMA/CHMP/730723/2017 of May 2018) we find:

T_max is not an end point to be included in the statistical analysis but a comparison of the values should be made and any differences discussed in the context of the application (see later).

This response could be understand that a comparison of t_max should only be discussed. Regrettably there was nothing to be ‘seen later’.
Funny enough the PKWP’s own statement didn’t make it to guidance of May 2018.

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Helmut Schütz

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Complete thread:

EMA: New product-specific guidances Helmut 2022-04-08 15:17
- How would you implement it? ElMaestro 2022-04-09 11:45
  - Confuse a Cat Inc. Helmut 2022-04-09 18:40
    - Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
      - Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
        
        Confuse a Cat Inc. Helmut 2022-04-11 13:59
        
        Range Ohlbe 2022-04-11 15:48
        
        Range Helmut 2022-04-11 16:07
        
        Range Ohlbe 2022-04-11 16:20
        
        RangeHelmut 2022-07-28 14:43
      - So many questions, so few answers Helmut 2022-04-11 13:03
      - Preliminary simulations Helmut 2022-04-30 14:59
        
        Preliminary simulations ElMaestro 2022-04-30 19:10
        
        Preliminary simulations Helmut 2022-05-01 15:56
        Revisions of the PSGLs final Helmut 2023-06-23 13:29
        
        Revisions of the PSGLs final dshah 2023-06-28 14:43
        
        EMA: No problems with many sampling time points… Helmut 2023-06-28 15:59
        New simulations & some desultory thoughts Helmut 2023-06-29 11:34
        
        SCNR. A heretic alternative. Helmut 2023-06-30 11:50
      - Simulated distributions Helmut 2022-05-02 13:43