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Dr_Dan ★★ Germany, 2013-06-26 13:24 (4752 d 05:22 ago) Posting: # 10882 Views: 2,634 |
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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 |
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Helmut ★★★ ![]() Vienna, Austria, 2013-06-26 15:39 (4752 d 03:07 ago) @ Dr_Dan Posting: # 10883 Views: 2,159 |
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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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![]() Helmut Schütz ![]() The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |

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