Bioequivalence and Bioavailability Forum • Fasting vs Fed study

Fasting vs Fed study [Power / Sample Size]

posted by sam – India, 2012-11-26 10:49 (4959 d 01:59 ago) – Posting: # 9590
Views: 22,154

Dear Sir,

Recently I performed a Fasting and Fed study on the prasugrel molecule. In fasting condition the AUC and Cmax is meeting the BE criteria with the ratio of around 100. But unfortunately in Fed condition the AUC is meeting the BE limit same as fasting but the Cmax fails with the ratio of more than 120 % and CI limits are wider enough.
kindly suggest me the probable reason for that, should I go for the reformulation or repeat the Fed study.
or any other reason.
Your esteemed reply is quite help for me to for the Exhibit batches and final pivotal study.

Edit: Category changed. [Helmut]

Complete thread:

Fasting vs Fed studysam 2012-11-26 09:49
- Prasugrel Helmut 2012-11-26 13:48
  - Prasugrel lukamar 2012-11-26 15:13
    - Prasugrel Helmut 2012-11-26 15:30
  - Prasugrel sam 2012-11-27 12:52
    - Prasugrel Dr_Dan 2012-11-27 14:19
    - Different ka and f Helmut 2012-11-27 14:56
      - Different ka and f? d_labes 2012-11-28 12:10
        
        Sorry. Forget it. Helmut 2012-11-28 15:42
        
        R code gem d_labes 2012-11-28 16:23
        
        R code gem Helmut 2012-11-28 16:54
      - Different ka and f sam 2012-11-28 12:38
        
        Different ka and f jag009 2012-11-29 16:30
    - Prasugrel jag009 2012-11-28 22:31
      - Prasugrel sam 2012-11-29 04:57
- Fasting vs Fed study drgunasakaran1 2012-11-27 14:17
  - For EU submission of Prasugrel venkata krishna 2013-02-23 06:40
    - EU: parent Helmut 2013-02-23 12:07