Bioequivalence and Bioavailability Forum • Presentations of the EUFEPS meeting

Presentations of the EUFEPS meeting [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-07-15 17:50 (3934 d 17:10 ago) – Posting: # 10977
Views: 18,955

Dear all,

below links to presentations of the EUFEPS meeting in Bonn last June:

Session I
General recommendations for pharmacokinetic studies with MR products of NCE and first MR form of compounds already approved as IR preparation
- Jan Welink (The Netherlands’ MEB, PKWP)
  The guideline on Pharmacokinetic and Clinical evaluation of modified release dosage forms. Introduction
- Σωτηρης Μιχαλεας – Sotiris Michaleas (Cyprus’ Ministry of Health, PKWP)
  Regulatory requirements and recommendations
- Jan Neuhauser (Austria’s AGES/PharmMed, PKWP)
  Understanding the proposed guideline for modified release
- Andrzej Dzierbicki (Polpharma)
  Comments compiled by the EUFEPS BABP Network
Session II
Assessment of BE for Abridged Applications
- Henrike Potthast (Germany’s BfArM, PKWP)
  BE in abridged applications
- Gerald Beuerle (Teva ratiopharm)
  Comments compiled by the EUFEPS BABP Network
Session III
Specific issues for BE assessment
- Alfredo García Arieta (Spain’s AEMPS, PKWP)
  Regulatory requirements and recommendations of the guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms
- Erich Brendel (ex-Bayer)
  Comments compiled by the EUFEPS BABP Network
Session IV
Appendices of the Guideline and TDDS
- Jan Neuhauser
  TDDS and Appendix I
- Alfredo García Aríeta
  In vitro in vivo correlation Appendix II of the guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms
- Erik Söderlind (AstraZeneca)
  Comments compiled by the EUFEPS BABP Network

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Helmut Schütz

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Complete thread:

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