Bioequivalence and Bioavailability Forum • Strange result

Strange result [Regulatives / Guidelines]

posted by jag009 – NJ, 2019-03-01 16:44 – Posting: # 19983
Views: 2,164

Hi Helmut!

» Was the study performed for Health Canada? In the 1989 draft 80–120% (untransformed data) were recommended and changed to 80–125% (log-transformed) in 1991.
» Then the study would have passed again cause –18.33% > –20% and –6.36% < +20%. However, the problem with the PE persists cause 100(–0.1833 + (–0.0636)) / 2 = –12.35% ≠ –6.14%. I don’t get it.

That I do not know (if it's for Canada) but it was a us study w US products. But your suggestion about Canada using non-transformed make sense(?) Can you tell me (or pt to me) about the Canadian guidance 89?

Thanks
J

Complete thread:

History lessons - FDA BE 90% CI jag009 2019-02-25 22:03 [Regulatives / Guidelines]
- History lessons - FDA BE 90% CI nobody 2019-02-25 22:39
  - History lessons - FDA BE 90% CI Helmut 2019-02-26 00:44
    - History lessons - FDA BE 90% CI jag009 2019-02-26 15:19
      - History lessons - FDA BE 90% CI nobody 2019-02-26 16:07
      - Strange result Helmut 2019-02-28 12:03
        
        Strange result nobody 2019-03-01 08:50
        
        Pandora's box? jag009 2019-03-01 17:40
        
        Confusing Helmut 2019-03-02 15:37
        
        Strange resultjag009 2019-03-01 17:44
        
        Transformation, acceptance range Helmut 2019-03-02 15:09
        
        Transformation, acceptance range nobody 2019-03-02 16:42