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RegisterEMA Steady State Fed Study breakfast [Regulatives / Guidelines]
Dear All,
As per EMA GL on MR products, for the Steady state studies of MR products under fed condition, the meal to be given prior to dosing is mentioned as "standard Meal", while in single dose fed studies it is stated as high fat meal.
So how should standard meal be around total of 700-800 kcal meal!!
Please provide your views on the same
Regards,
Jay
As per EMA GL on MR products, for the Steady state studies of MR products under fed condition, the meal to be given prior to dosing is mentioned as "standard Meal", while in single dose fed studies it is stated as high fat meal.
So how should standard meal be around total of 700-800 kcal meal!!
Please provide your views on the same
Regards,
Jay
Complete thread:
- EMA Steady State Fed Study breakfastJay 2015-06-02 12:43 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
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- EMA Steady State Fed Study breakfast Helmut 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
Ing. Helmut Schütz