Bioequivalence and Bioavailability Forum • Prasugrel

Prasugrel [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2012-11-26 16:30 (4549 d 09:33 ago) – Posting: # 9593
Views: 17,344

Hi Łukasz!

❝ 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.

True. But I don’t know whether Sam wants to apply in the EU.

❝ Based on fast study, Sam's formulation would be approved, although clearly it is not bioequivalent under fed conditions.

OK, for the FDA Sam would have to show BE fasting+fed. Even for EMA we have to show the synopsis of all studies performed during product development. Too bad that the C_max ratio was that high in fed state. I would expect questions approaching.

❝ 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.

I should have been more precise. EMA’s (and FDA’s) point of view generally is correct for most IR formulations. For MR formulations (more of the delayed release type) and IR formulations of drugs with presystemic metabolism and/or a high first pass (especially pro drugs), this might not be the case, IMHO.

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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
    - PrasugrelHelmut 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