Bioequivalence and Bioavailability Forum • Interval between groups

Interval between groups [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2017-05-08 21:02 (2543 d 17:53 ago) – Posting: # 17321
Views: 29,954

Hi mittyri and all,

the p-value of the Group-by-Treatment interaction seemingly does not depend on the interval between groups. In 51% of the studies the interval was three days or less but in some substantially longer (i.e., steady state studies where the clinic was occupied). The bubbles’ area, the linear regression, and the loess curve are scaled/weighed by the sample size.

[image]

slope: 0.011196 (p 0.165)

[image]

slope: 0.010589 (p 0.186)

Therefore, we should not worry. The FDA defines “greatly separated in time” as “months apart, for example”.

—
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Helmut Schütz

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Complete thread:

Russian «Экспертами» and their hobby Helmut 2017-04-29 00:46 [Regulatives / Guidelines]
- Low power of Group-by-Treatment interaction mittyri 2017-04-29 22:57
  - Let’s forget the Group-by-Treatment interaction, please! Helmut 2017-04-30 13:54
    - Let’s forget the Group-by-Treatment interaction, please! ElMaestro 2017-05-01 16:19
      - Some answers Helmut 2017-05-02 01:10
        
        Some answers ElMaestro 2017-05-02 09:04
        
        Example Helmut 2017-05-02 12:35
        
        Sensitivity of term? mittyri 2017-05-02 18:29
        
        Simulations Helmut 2017-05-05 14:38
        
        loosing specificity due to low sensitivity mittyri 2017-05-08 23:28
        
        loosing specificity due to low sensitivity Helmut 2017-05-09 00:55
        
        Loss in power Helmut 2017-05-06 17:31
        Interval between groupsHelmut 2017-05-08 19:02
        
        IMP handling mittyri 2017-05-08 23:40
        
        IMP handling Helmut 2017-05-09 01:08
        
        Loss in power Helmut 2017-05-14 17:22
      - No convergence in JMP and Phoenix WinNonlin Helmut 2017-05-25 15:26
        
        Ouch?!??? ElMaestro 2017-05-25 16:24
- Russian «Экспертами» and their hobby Artem Gusev 2017-05-02 16:13
  - be careful with mixed models mittyri 2017-05-02 17:53
    - be careful with mixed models Artem Gusev 2017-05-03 11:02
  - p-value(s) in model 2 Helmut 2017-05-05 14:48
- Russian «Экспертами» following the EEU GLs Helmut 2017-05-24 20:17
  - Russian «Экспертами» following the EEU GLs Beholder 2017-05-24 22:37
    - Penalty for carelessness mittyri 2017-05-25 08:52
    - Russian «Экспертами» following the EEU GLs Beholder 2017-05-25 10:43
  - Russian «Экспертами» following the EEU GLs Mikalai 2018-01-04 10:43
    - Belarus = member of the EEU Helmut 2018-01-04 13:08
      - Belarus = member of the EEU Mikalai 2018-01-04 19:49
      - Trying your model for EEU mittyri 2018-01-04 22:04
        
        Trying your model for EEU Helmut 2018-01-05 00:06
        
        help us to stop it, please... Astea 2018-01-10 12:09
        
        help us to stop it, please... Beholder 2018-01-10 12:49
        regulators convinced by science? d_labes 2018-01-10 15:15
        
        regulators convinced by science? Beholder 2018-01-10 17:14
        
        Чёрт побери! d_labes 2018-01-10 18:53
        
        regulators convinced by science? Astea 2018-01-10 19:10
        
        Excuse me d_labes 2018-01-10 20:18
        
        Excuse me Astea 2018-01-10 20:38