Bioequivalence and Bioavailability Forum • Pandora's box?

Pandora's box? [Regulatives / Guidelines]

posted by jag009 – NJ, 2019-03-01 18:40 (2173 d 05:26 ago) – Posting: # 19982
Views: 6,732

Hi Guys (and Gals!),

It's a 2-way crossover US study (definitely not anywhere else, clinical done in 1990 so was report). Here is the exact wordings from the table (if that makes any difference to what I posted). Note that the summary table also presented +/- Westlake 95% CI..

Cmax(n=24):
Detectable differences(%)=13.28
T/R Ratio=93.86%
+/- Westlake 95% CI=20.12%
One sided t-test 90% CI:Lower limit= -18.33%, Upper Limit= -6.36%

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 result jag009 2019-03-01 17:44
        
        Transformation, acceptance range Helmut 2019-03-02 15:09
        
        Transformation, acceptance range nobody 2019-03-02 16:42