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RegisterEMA approval regulations for Incrementally Modified Drug [Regulatives / Guidelines]
I have some questions about authorisation for Incrementally Modified Drug.
TriCor3 (fenofibrate) case is similar with us. TriCor3 is IMD derived from TriCor2 which have to be administered with food (but TriCor3 can be administered with or without food). We want get an authorisation for our IMD which (like TriCor3) eliminate food effect. I wonder that we could get an approval with just fasted/fed condition bioequivalence study for test and reference. And if we already got an approval for our high strength IMD, could our low strength IMD get an approval without additional BE test? (in vitro comparative dissolution test is enough for low? Dose proportionality in fed condition has been confirmed in many articles)
TriCor3 (fenofibrate) case is similar with us. TriCor3 is IMD derived from TriCor2 which have to be administered with food (but TriCor3 can be administered with or without food). We want get an authorisation for our IMD which (like TriCor3) eliminate food effect. I wonder that we could get an approval with just fasted/fed condition bioequivalence study for test and reference. And if we already got an approval for our high strength IMD, could our low strength IMD get an approval without additional BE test? (in vitro comparative dissolution test is enough for low? Dose proportionality in fed condition has been confirmed in many articles)
Complete thread:
- EMA approval regulations for Incrementally Modified Druglovemysoul 2014-05-13 03:42
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Ing. Helmut Schütz