Bioequivalence and Bioavailability Forum • Overview of comments published

Overview of comments published [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2010-02-10 19:33 (5965 d 23:30 ago) – Posting: # 4746
Views: 27,661

Dear all,

the “Overview of Comments Received on Draft Guideline on the Investigation of Bioequivalence” (EMA/CHMP/EWP/26817/2010) was published today.
As expected the document is quite heavy (248 pages).
Enjoy, but take your time!

An interesting one (page 157) for people following the MR-guideline (Whenever multiple dose studies are performed it should be demonstrated that steady state has been reached):

Achievement of steady state can be evaluated by collecting pre-dose samples on the day before the PK assessment day and on the PK assessment day. A specific statistical method to assure that steady state has been reached is not considered necessary in bioequivalence studies. Descriptive data is sufficient.

No need for a statistical test (at least for EMA). I have to revise my previous recommendations (like in this post).

A comment on replicate designs (page 185) As there is still some controversy around replicate design studies and the statistical analysis, it would be very helpful if more detailed recommendations could be given here. What statistical analyses to be used? How to evaluate a replicate design in an average BE approach?
Was answered by

It is out of the scope of the guideline to give details on how to analyse the data of a replicate design, since it is standard statistical analysis.

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Complete thread:

EMA BE guideline - final version Ohlbe 2010-01-28 18:31 [Regulatives / Guidelines]
- 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-analysis Helmut 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 publishedHelmut 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