Bioequivalence and Bioavailability Forum • Meta-analysis

Meta-analysis [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2010-02-07 18:41 (5986 d 01:52 ago) – Posting: # 4727
Views: 27,523

Dear all!

Meta-analysis was not acceptable in the draft (see this post), but made it to the final GL (Section 4.1.8 Evaluation / Presentation of data):

If for a particular formulation at a particular strength multiple studies have been performed some of which demonstrate bioequivalence and some of which do not, the body of evidence must be considered as a whole. Only relevant studies […] need be considered. The existence of a study which demonstrates bioequivalence does not mean that those which do not can be ignored. The applicant should thoroughly discuss the results and justify the claim that bioequivalence has been demonstrated. Alternatively, when relevant, a combined analysis of all studies can be provided in addition to the individual study analyses. It is not acceptable to pool together studies which fail to demonstrate bioequivalence in the absence of a study that does.

(my emphasis)

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Complete thread:

EMA BE guideline - final version Ohlbe 2010-01-28 18:31
- Final version published Helmut 2010-01-29 14:29
  - Final version published ElMaestro 2010-01-29 17:02
    - Statistix Helmut 2010-01-29 17:30
      - Statistix ElMaestro 2010-01-29 18:11
    - Calories ;-) Helmut 2010-01-29 19:22
      - Calories ;-) ElMaestro 2010-01-29 20:43
        
        Calories ;-) Helmut 2010-01-29 21:08
      - Variable calories d_labes 2010-02-01 12:05
    - ANOVA only - no doubts Helmut 2010-02-10 23:41
      - ANOVA only - no doubts ElMaestro 2010-02-12 21:09
  - Final EMA oracle d_labes 2010-02-01 11:53
    - Final EMA oracle Helmut 2010-02-01 12:28
    - Final EMA oracle ElMaestro 2010-02-01 12:50
      - More then two EMA oracles d_labes 2010-02-01 13:30
        
        Less of an issue ElMaestro 2010-02-01 15:29
        
        Less or More of an issue d_labes 2010-02-01 16:53
        
        Less or More of an issue ElMaestro 2010-02-01 17:22
        
        Effective with 1 Aug 2010 Helmut 2010-02-02 00:55
        Bias? ElMaestro 2010-02-04 11:27
        
        Bias? Helmut 2010-02-05 02:03
        
        Bias? ElMaestro 2010-02-05 09:33
        
        Bias? Helmut 2010-02-05 10:21
        
        Bias? d_labes 2010-02-05 13:59
        Bias? ElMaestro 2010-02-05 16:00
        
        Bias? Helmut 2010-02-05 19:14
      - Final EMA oracle Helmut 2010-02-01 13:43
        
        Final EMA oracle ElMaestro 2010-02-01 14:54
        
        Final EMA oracle d_labes 2010-02-01 15:20
        
        Teaching Helmut 2010-02-01 16:07
  - Cmin really gone? tmax reappeared? d_labes 2010-02-01 14:02
    - Cmin really gone. tmax reappeared - but how? Helmut 2010-02-01 23:30
  - Interpol or not d_labes 2010-02-01 14:52
    - Interpol! Helmut 2010-02-02 00:02
      - Interpol! ray_be 2010-02-03 18:31
        
        WinNonlin/Phoenix extrapolation to t=tau Helmut 2010-02-03 20:26
  - Meta-analysisHelmut 2010-02-07 17:41
  - Final version published Panks.79 2010-03-08 07:22
    - Cmin for MR-formulations? Helmut 2010-03-08 18:16
      - Cmin for MR-formulations? Marcel 2010-04-23 10:09
        
        MR-Guideline? Helmut 2010-04-23 12:34
- Overview of comments published Helmut 2010-02-10 18:33
  - Comments commented d_labes 2010-02-11 08:19
  - Definition of Cmin by EMEA Ravi 2010-03-13 12:05
    - The EMA’s Cmin & WinNonlin Helmut 2010-03-13 12:52