Bioequivalence and Bioavailability Forum • To Abreviate or not to Abreviate

To Abreviate or not to Abreviate [Regulatives / Guidelines]

posted by KR – India, 2010-04-26 08:03 (5905 d 21:56 ago) – Posting: # 5223
Views: 18,538

Dear EM,

Thanks for the reply. The main problem is how does the Emax model given in the OGD guidance give the output as the same dose (i.e. 60 mg tid or 2 x 60 mg tid) for both test and reference will be given to all the volunteers and hence, how to establish dose response relationship ?

Thanks...

KR

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post. [Helmut]

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 AbreviateKR 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