Bioequivalence and Bioavailability Forum • To Abreviate or not to Abreviate

To Abreviate or not to Abreviate [Regulatives / Guidelines]

posted by GSTATS – India, 2010-05-27 20:30 (5873 d 08:56 ago) – Posting: # 5389
Views: 18,653

Dear KR,

As per my understanding, if i am not wrong FDA wants you to conduct a three way crossover study with two doses of reference and then fitting an Emax model (as given in recommendation) for reference which will provide estimated values of parameters used in model.
Put those estimated values again in model for test product as response and find relative bioavailability (F) of test with respect to reference.

And 90% confidence intervals for "F" can be calculated by repetitive sampling method using Bootstrap procedure.

I hope this will help you.

Regards,
GSTATS
http://gstatsolutions.com/Medical%20Research.html

—
Let Noble Thoughts come from Every Side: RIG VEDA

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 AbreviateGSTATS 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