Bioequivalence and Bioavailability Forum • My lack of understanding

My lack of understanding [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2010-05-29 05:32 (5876 d 09:33 ago) – Posting: # 5397
Views: 18,369

Hi Gstats,

❝ And we can use Baseline response in the absence of the drug as third dose level and make a fair fit to that model for ref.

I am afraid I am not able to see the practical applicability of that; for any data point associated with ref. there will be two dose levels, or perhaps three if you're right this will only be the case if we assume E_min is the same for both test and ref. (reasonable, if you ask me) and equal to the effect at run-in. The latter lacks qualification and I would really be surprised if the FDA would allow that kind of assumption. It would not fit into my image of those gents.

Mystified and still curious to see how this would work in practise.
EM.

—
Pass or fail!
ElMaestro

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 Abreviate ElMaestro 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 understandingElMaestro 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