Bioequivalence and Bioavailability Forum • Prasugrel

Prasugrel [Power / Sample Size]

posted by lukamar – Poland, 2012-11-26 16:13 (4537 d 02:51 ago) – Posting: # 9592
Views: 17,198

Hello everyone,
As per reference product SmPC prasugrel may be administered with or without food. Wchich means that in EU one study under fasting conditions would be sufficent. Based on fast study, Sam's formulation would be approved, although clearly it is not bioequivalent under fed conditions. Taking this into consideration and this Helmut's statement:

❝ General remark: For the majority of formulations BE in fed state is more difficult to show than in fasted state.

what rationale for this guideline wording:
"In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations." is?
In this case it looks like it is totally other way round.
Best regards,
Łukasz

Complete thread:

Fasting vs Fed study sam 2012-11-26 09:49
- Prasugrel Helmut 2012-11-26 13:48
  - Prasugrellukamar 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