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Registertlag‽ [Regulatives / Guidelines]
...somebody had a look at the ADRs (mostly upper GI-tract-related, therefore the gastroresistant formulation) and said, hey, we have to "quantitate" the quality of the gastroresistant part of the formulations. Let's do tlag!
afaik the SmPC recommends application in fed state, due to better tolerability. The EMA guideline gives no recommendation re. fasted/fed?!
On the other hand: Modified release with one single-dose study only?
afaik the SmPC recommends application in fed state, due to better tolerability. The EMA guideline gives no recommendation re. fasted/fed?!
On the other hand: Modified release with one single-dose study only?
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Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- EMA Product Specific GL mmw 2017-07-14 14:50
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Ing. Helmut Schütz