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RegisterDraft 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
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
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Draft EMA MR formulations GL; fasted vs. fedDr_Dan 2013-06-26 11:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Corridor approach Helmut 2013-06-26 13:39
Ing. Helmut Schütz