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RegisterGeneric product of fixed dose combination product [Regulatives / Guidelines]
"...In this case two pharmacokinetics bridges may need to be built..."
Emphasis on may, I guess
Would strongly depend on the clinical data available for R(AB), I assume, if you have to go this way.
You could offer some food offerings to the oracle or some thousand bugs for an SA, to get the official answer to your questions. In fact I believe, you need both BE studies of your option 1 to pass plus an explanation for "no drift relevant" in practice, if you have clinical data only for combi of the monopreparations. FDC can be real pain...
Edit: Please don’t shout! [Helmut]
Emphasis on may, I guess
Would strongly depend on the clinical data available for R(AB), I assume, if you have to go this way.
You could offer some food offerings to the oracle or some thousand bugs for an SA, to get the official answer to your questions. In fact I believe, you need both BE studies of your option 1 to pass plus an explanation for "no drift relevant" in practice, if you have clinical data only for combi of the monopreparations. FDC can be real pain...
Edit: Please don’t shout! [Helmut]
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- Generic product of fixed dose combination product Shuanghe 2017-05-16 18:33 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Generic product of fixed dose combination productnobody 2017-05-16 19:17
- Generic product of fixed dose combination product varun9461 2017-11-30 11:03
Ing. Helmut Schütz