Bioequivalence and Bioavailability Forum • RSABE

RSABE [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-03-24 18:25 (4480 d 08:56 ago) – Posting: # 12696
Views: 12,975

Hi Lucas,

see FDA’s progesterone guidance containing SAS-code. If you don’t have SAS, see this post for Phoenix/WinNonlin. Some background about FDA’s/EMA’s approaches.
The problems with FDA’s mixed-effects model start if you are not allowed to scale (CV_WR<30%) and have a partial replicate design. Sometimes software (with the FA0(2) covariance structure given in the guidance) fails to converge. Then you have invested in a lot of money and don’t get a result…
I would avoid the partial replicate TRR|RTR|RRT and opt for one of the fully replicated designs (TRT|RTR or TRTR|RTRT) instead.

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Helmut Schütz

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Complete thread:

Draft FDA Guidance Dec 2013 pash413 2013-12-04 15:05
- First impressions Helmut 2013-12-04 16:47
  - First impressions nasir 2014-02-14 06:47
- What is Bioequivalence in the US really? ElMaestro 2013-12-07 23:34
  - Site of action vs. systemic circulation Helmut 2013-12-08 02:05
- Draft FDA Guidance Dec 2013 drgunasakaran1 2013-12-08 08:39
  - Two-stage or RSABE Helmut 2013-12-08 13:59
    - Two-stage or RSABE ElMaestro 2013-12-08 14:17
      - Two-stage methods Helmut 2013-12-08 14:44
        
        Two-stage methods ElMaestro 2013-12-08 18:56
    - RSABE Lucas 2014-03-24 17:05
      - RSABEHelmut 2014-03-24 17:25
        
        RSABE Lucas 2014-03-25 13:33
        
        RSABE Helmut 2014-03-25 14:31
        
        RSABE Lucas 2014-03-26 15:19
        
        RSABE Helmut 2014-03-26 15:28
  - Draft FDA Guidance Dec 2013 jag009 2013-12-09 22:31
    - Draft FDA Guidance Dec 2013 kvgreddy06 2014-02-14 16:44
- End of consultation approaching‼ Helmut 2014-02-26 11:32
  - End of consultation approaching‼ wien-ui 2014-03-01 08:05
    - End of consultation approaching‼ Helmut 2014-03-01 20:09
      - End of consultation approaching‼ wien-ui 2014-03-04 10:53