Bioequivalence and Bioavailability Forum • More then two EMA oracles

More then two EMA oracles [Regulatives / Guidelines]

posted by d_labes – Berlin, Germany, 2010-02-01 14:30 (5975 d 10:41 ago) – Posting: # 4677
Views: 27,607

Großer Meister,

❝ Contrary to HS' opinion, I think this is exactly how that sentence should be interpreted for now. I would not be surprised if a slight revision is due soon which addresses this issue and/or the fixed factor problem.

I can't believe that :no:

! We have only one study! And shall treat them as if we had some independent 2×2 studies?

What if we have period effects? In the '2×2 extracted evaluation' we are then mixing periods (for instance in T1T2R for the pair T1/R T1 comes from period 1, in sequence T2T1R from period 2).

And what about sequences? For the above example T1T2R and T2T1R are the same in evaluating T1/R?

And what about the error (MSE). In the 3×3 cross-over we have then two (distinct) MSE's and also CV's?

Questions over questions. With the simple answer: This is statistically not so very sound, to be political correct (and not saying nonsense).

Hopefully this will be cleared before the magic 10-Aug-2010.

Regarding the fixed effects issue you questioned above in your post:
I can't imagine, what this means at all :ponder:

, especially if I think about the sequence test. Shall we use the error term as the denominator as is in a fully fixed effects model?
We all know that this is the wrong (already Grizzle in his basic paper noticed the right denominator is the subject(sequence) MS).

Hopefully this will be clarified before the magic 10-Aug-2010.

JE Grizzle
The two-period change over design and its use in clinical trials
Biometrics 21, 467-480 (1965)
[Helmut]

—
Regards,

Detlew

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 oraclesd_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 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