Generic product of fixed dose combination product [Regulatives / Guidelines]

posted by nobody – 2017-05-16 21:17 (2928 d 10:59 ago) – Posting: # 17360
Views: 6,249

"...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]
—
Kindest regards, nobody

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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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