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RegisterPrasugrel [Power / Sample Size]
posted by Helmut 
– Vienna, Austria, 2012-11-26 14:48 (4549 d 13:02 ago) – Posting: # 9591
Views: 17,513
Dear Madam,
which regulation are you aiming at? Which compound – parent, metabolite(s) – have you measured?
FDA wants to see two metabolites: R-95813 (inactive) and R-138727 (active); BE based on the inactive R-95813.
Following what EMA stated in the Q&A-document on clopidogrel I would expect that they want to see BE based on the parent. Only if you can justify that it is not possible to reliable measure the parent you can go with one of the metabolites – active or inactive (BE GL).
With a ratio of >120% it is very (very!) unlikely that you will be able to show BE in a larger study. Reformulate.
General remark: For the majority of formulations BE in fed state is more difficult to show than in fasted state. It is beyond my intellectual reach why many companies start with the fasted study only to find out that they fail in the fed. Reverse the order and save money.
Send me a pay-check for the tip.
which regulation are you aiming at? Which compound – parent, metabolite(s) – have you measured?
FDA wants to see two metabolites: R-95813 (inactive) and R-138727 (active); BE based on the inactive R-95813.
Following what EMA stated in the Q&A-document on clopidogrel I would expect that they want to see BE based on the parent. Only if you can justify that it is not possible to reliable measure the parent you can go with one of the metabolites – active or inactive (BE GL).
With a ratio of >120% it is very (very!) unlikely that you will be able to show BE in a larger study. Reformulate.
General remark: For the majority of formulations BE in fed state is more difficult to show than in fasted state. It is beyond my intellectual reach why many companies start with the fasted study only to find out that they fail in the fed. Reverse the order and save money.
Send me a pay-check for the tip.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Fasting vs Fed study sam 2012-11-26 09:49 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PrasugrelHelmut 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
- R code gem d_labes 2012-11-28 16:23
- Sorry. Forget it. Helmut 2012-11-28 15:42
- Different ka and f sam 2012-11-28 12:38
- Different ka and f jag009 2012-11-29 16:30
- Different ka and f? d_labes 2012-11-28 12:10
- Prasugrel jag009 2012-11-28 22:31
- Prasugrel sam 2012-11-29 04:57
- Prasugrel lukamar 2012-11-26 15:13
- 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
- For EU submission of Prasugrel venkata krishna 2013-02-23 06:40
- PrasugrelHelmut 2012-11-26 13:48
Ing. Helmut Schütz