Bioequivalence and Bioavailability Forum • Different ka and f

Different ka and f [Power / Sample Size]

posted by sam – India, 2012-11-28 13:38 (4547 d 12:09 ago) – Posting: # 9615
Views: 16,669

Dear Helmut

It’s a nice Joke and I am very glad that I have added your joke in my memories.
Thanks for your nice and explanatory mail.
In case of the Fed study the ISCV is more than 30%. Based on that should I go for the partially or fully replicate design along with the reformulation.
Since this I am adding one more variable like partially replicate and fully replicate and second variable is reformulation. So I am bit doubtful will it be a wise decision to go with both the variables in a singly time to save the time lines.
Plz also suggest if this is really a highly variable drug product with some references, if possible.
Hope for the positive reply.

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 fsam 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