EMA Steady State Fed Study breakfast [Regulatives / Guidelines]
Hi MMW,
Do you really still hope that – after more than two years of broken promises – the comments will ever be published? C’mon!
If (!) administration in fed state is recommended in the SmPC of the originator, yes.
If not (the SmPC allows fasting or fed), no idea. Too bad, that we don’t have the comments for clarification. In the SD study testing the food effect a high-fat high-calory meal is mandatory. What if an assessor wants the same on profile days? No idea. If you prefer to wear a belt plus suspenders, opt for ascientific regulatory advice.
❝ ❝ • […] We are all waiting since last November for the PKWP’s comments to be published. Promised for “the next week” a couple of times (Amsterdam March, London April, Budapest May)…
❝
❝ I am going through EMA's website and searching for comments on GL for modified release dosage form. But could not get it. Whether they published comments or not?
Do you really still hope that – after more than two years of broken promises – the comments will ever be published? C’mon!
❝ […] I am designing fed MD study for a prolonged release formulation. Should I go for normo-caloric meals […] throughout the study including profiling day. This will comply with present GL, right?
If (!) administration in fed state is recommended in the SmPC of the originator, yes.
If not (the SmPC allows fasting or fed), no idea. Too bad, that we don’t have the comments for clarification. In the SD study testing the food effect a high-fat high-calory meal is mandatory. What if an assessor wants the same on profile days? No idea. If you prefer to wear a belt plus suspenders, opt for a
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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
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:
- EMA Steady State Fed Study breakfast Jay 2015-06-02 12:43
- EMA Steady State Fed Study breakfast jag009 2015-06-19 20:57
- EMA Steady State Fed Study breakfast Helmut 2015-06-23 00:25
- EMA Steady State Fed Study breakfast nobody 2015-06-23 09:11
- EMA Steady State Fed Study breakfast mmw 2017-08-23 10:00
- EMA Steady State Fed Study breakfastHelmut 2017-08-23 18:14
- EMA Steady State Fed Study breakfast Helmut 2015-06-23 00:25
- EMA Steady State Fed Study breakfast jag009 2015-06-19 20:57