Presentations of the EUFEPS meeting [Regulatives / Guidelines]
Dear all,
below links to presentations of the EUFEPS meeting in Bonn last June:
Session II
Assessment of BE for Abridged Applications
Session III
Specific issues for BE assessment
Session IV
Appendices of the Guideline and TDDS
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
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
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
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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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Draft EMA MR formulations GL published! Ohlbe 2013-03-15 12:10 [Regulatives / Guidelines]
- Housekeeping suggestions Helmut 2013-03-15 13:28
- Scaling for pAUCs Helmut 2013-03-15 14:19
- Draft EMA MR formulations GL published! ioanam 2013-03-30 17:54
- Topicals → 1995 NfG Helmut 2013-03-30 22:51
- Topicals, generic ElMaestro 2013-03-31 19:26
- Topicals, generic ioanam 2013-04-01 07:51
- Topicals, generic The Outlaw Torn 2013-04-01 08:03
- Topicals, generic ioanam 2013-04-01 07:51
- Clarity on waiving multiple dose study Tina 2013-05-15 14:19
- Hey, it is just a draft! Helmut 2013-05-17 18:49
- Critical review of García-Arieta et al. (2012) Helmut 2013-06-29 19:44
- Hey, it is just a draft! Helmut 2013-05-17 18:49
- SD vs. MD, partial AUCs Helmut 2013-06-21 19:24
- SD vs. MD, partial AUCs Shuanghe 2013-06-25 17:22
- SD vs. MD, partial AUCs Helmut 2013-06-25 19:15
- SD vs. MD, partial AUCs Shuanghe 2013-06-27 11:07
- pAUCs, alternative metrics, alcohol Helmut 2013-06-27 14:38
- SD vs. MD, partial AUCs Shuanghe 2013-06-27 11:07
- SD vs. MD, partial AUCs Helmut 2013-06-25 19:15
- SD vs. MD, partial AUCs Shuanghe 2013-06-25 17:22
- tmax (DR & multiphasic) Helmut 2013-06-22 01:15
- Presentations of the EUFEPS meetingHelmut 2013-07-15 15:50
- ⧫ Deadline approaching ⧫ Helmut 2013-08-16 16:41
- Download comment form Helmut 2013-08-26 11:28
- Food effect Compliance 2013-08-26 12:04
- Food effect Dr_Dan 2013-08-26 16:48
- Variability (MR vs. IR) Helmut 2013-09-12 15:23