Bioequivalence and Bioavailability Forum • For EU submission of Prasugrel

For EU submission of Prasugrel [Power / Sample Size]

posted by venkata krishna – India, 2013-02-23 07:40 (4460 d 18:13 ago) – Posting: # 10111
Views: 15,776

Dear Dr. Gunasakaran,

We are going prasugrel for EU submission. Kindly advise which metabolite to be evaluate (i.e R 95913 or R 138727) and show bio equivalence.

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

—
Regards,
krishna

Complete thread:

Fasting vs Fed study sam 2012-11-26 09:49 [Power / Sample Size]
- 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 Prasugrelvenkata krishna 2013-02-23 06:40
    - EU: parent Helmut 2013-02-23 12:07