Bioequivalence and Bioavailability Forum • My lack of understanding

My lack of understanding [Regulatives / Guidelines]

posted by GSTATS – India, 2010-05-29 07:28 (5500 d 11:04 ago) – Posting: # 5398
Views: 16,791

Hi Elmaestro,

❝ 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.

Emin or E0 is same for both test and reference as it is a value obtained in run in period when dose level is zero and FDA has mentioned in there recommendation that "This modified model is based on assumption that both E0 and Emax are the same for the test and reference products".

GSTATS
http://www.gstatsolutions.com/Clinical%20Research.html

—
Let Noble Thoughts come from Every Side: RIG VEDA

Complete thread:

Orlistat Bioequivalence KR 2010-04-23 06:14 [Regulatives / Guidelines]
- 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 understanding ElMaestro 2010-05-29 03:32
        
        My lack of understandingGSTATS 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