Dr_Dan
★★  

Germany,
2013-06-26 13:24
(4752 d 05:22 ago)

Posting: # 10882
Views: 2,634
 

 Draft EMA MR formulations GL; fasted vs. fed [Regulatives / Guidelines]

Dear all
Does anybody attending the EUFEPS Open Discussion Forum on the Revised European Guideline on Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms remember what the outcome of Gerald Beuerle’s corridor approach regarding food effect was?
If the fasted study demonstrates bioequivalence between test and reference and if the bioavailability of the active substance in the fed state is lower than in the fasted state but higher in the test product than in the reference product (=no bioequivalence, however safety and efficacy not affected) would the test product still be regarded as approvable?
As far as I remember no consensus was reached, right?
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan
Helmut
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Vienna, Austria,
2013-06-26 15:39
(4752 d 03:07 ago)

@ Dr_Dan
Posting: # 10883
Views: 2,159
 

 Corridor approach

Hi Dan!

As far as I recall the corridor approach might be (!) applicable for the innovator (e.g., in a line extension) but not for generics. Ask Gerald; I bet he was following the discussion more closely than I did.

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