Manolis, E;
Brogren, J;
Cole, S;
Pittaway-Hay, J;
Nordmark, A;
Karlsson, KE;
Lentz, F;
... EMA MSWG Group; + view all
(2017)
Commentary on the MID3 Good Practices Paper.
CPT: Pharmacometrics & Systems Pharmacology
, 6
(7)
pp. 416-417.
10.1002/psp4.12223.
Preview |
Text
Commentary on the MID3 Good Practices Paper.pdf - Published Version Download (73kB) | Preview |
Abstract
During the last 10 years the European medicines Agency (EMA) organised a number of workshops on modelling and simulation, working towards greater integration of modelling and simulation (M&S) in the development and regulatory assessment of medicines. In the 2011 EMA - European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on Modelling and Simulation European regulators agreed to the necessity to build to expertise be able to review M&S data provided by companies in their dossier. This lead to the establishment of the EMA modelling and simulation working group (MSWG). Also there was agreement reached on the need for harmonisation on good M&S practices and for continuing dialogue across all parties. The MSWG acknowledges the initiative of the EFPIA Model-Informed Drug Discovery and Development (MID3) group in promoting greater consistency in practice, application and documentation of M&S and considers the paper is an important contribution towards achieving this objective.
| Type: | Article |
|---|---|
| Title: | Commentary on the MID3 Good Practices Paper |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1002/psp4.12223 |
| Publisher version: | http://dx.doi.org/10.1002/psp4.12223 |
| Language: | English |
| Additional information: | Copyright © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Infection, Immunity and Inflammation Dept |
| URI: | https://discovery.ucl.ac.uk/id/eprint/1560514 |
Archive Staff Only
 |
View Item |
