Bioequivalence and Bioavailability Forum • To Abreviate or not to Abreviate

To Abreviate or not to Abreviate [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2010-04-24 10:16 (5909 d 20:26 ago) – Posting: # 5210
Views: 18,638

Dear KR,

sorry if I contributed to the obfuscation of your thread.
I read briefly through the document from the OGD and it does confuse me somewhat.
As far as I can tell, this calls for an assessment of relative potency via a rudimentary dose-response curve and bootstrap. Validating a stats package for the botstrap is one hurdle in itself.

But, actually, in order to assess relative potency I would believe that something more complex than a three-arm study would be needed, so I cannot tell you exactly which groups to have. I cannot tell if the FDA wants to see just the dose-response for Ref and then a single point of Test. If they will accept it, it would to me seem to be three arms and should be easy, but does the Emax model given in the document really allow for that?

Best regards
EM.

Complete thread:

Orlistat Bioequivalence KR 2010-04-23 06:14
- To Abreviate or not to Abreviate d_labes 2010-04-23 09:28
  - What was really meant ElMaestro 2010-04-23 09:50
    - OGD Guidance Helmut 2010-04-23 12:42
  - To Abreviate or not to Abreviate KR 2010-04-23 15:01
    - Calm and serene d_labes 2010-04-23 15:47
    - To Abreviate or not to AbreviateElMaestro 2010-04-24 08:16
      - To Abreviate or not to Abreviate KR 2010-04-26 06:03
        
        To Abreviate or not to Abreviate GSTATS 2010-05-27 18:30
        
        My lack of understanding ElMaestro 2010-05-28 00:54
        
        My lack of understanding GSTATS 2010-05-28 17:03
        
        My lack of understanding ElMaestro 2010-05-29 03:32
        
        My lack of understanding GSTATS 2010-05-29 05:28
        
        My lack of understanding KR 2010-05-31 08:51
        
        My lack of understanding ElMaestro 2010-06-01 16:13
        
        Calculation sangeeta 2011-11-29 17:58
        
        Calculation ElMaestro 2011-11-29 18:09
        
        Calculation sangeeta 2011-11-29 18:30
        
        Calculation ElMaestro 2011-11-30 11:35