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CPT: pharmacometrics & systems pharmacology
07, 2017;6 (7): 416-417.

Commentary on the MID3 Good Practices Paper.

Efthymios Manolis, Jacob Brogren, Susan Cole, Justin L Hay, Anna Nordmark, Kristin E Karlsson, Frederike Lentz, Norbert Benda, Gaby Wangorsch, Gerard Pons, Wei Zhao, Valeria Gigante, Francesca Serone, Joseph F Standing, Aris Dokoumetzidis, Juha Vakkilainen, Michiel van den Heuvel, Victor Mangas Sanjuan, Johannes Taminiau, Essam Kerwash, David Khan, Flora Tshinanu Musuamba, Ine Skottheim Rusten, EMA Modelling and Simulation Working Group
Author Information
  1. Efthymios Manolis: European Medicines Agency, London, UK.
  2. Jacob Brogren: EMA Modelling and Simulation Working Group.
  3. Susan Cole: EMA Modelling and Simulation Working Group.
  4. Justin L Hay: EMA Modelling and Simulation Working Group.
  5. Anna Nordmark: EMA Modelling and Simulation Working Group.
  6. Kristin E Karlsson: EMA Modelling and Simulation Working Group.
  7. Frederike Lentz: EMA Modelling and Simulation Working Group.
  8. Norbert Benda: EMA Modelling and Simulation Working Group.
  9. Gaby Wangorsch: EMA Modelling and Simulation Working Group.
  10. Gerard Pons: EMA Modelling and Simulation Working Group.
  11. Wei Zhao: EMA Modelling and Simulation Working Group.
  12. Valeria Gigante: EMA Modelling and Simulation Working Group.
  13. Francesca Serone: EMA Modelling and Simulation Working Group.
  14. Joseph F Standing: EMA Modelling and Simulation Working Group.
  15. Aris Dokoumetzidis: EMA Modelling and Simulation Working Group.
  16. Juha Vakkilainen: EMA Modelling and Simulation Working Group.
  17. Michiel van den Heuvel: EMA Modelling and Simulation Working Group.
  18. Victor Mangas Sanjuan: EMA Modelling and Simulation Working Group.
  19. Johannes Taminiau: EMA Modelling and Simulation Working Group.
  20. Essam Kerwash: EMA Modelling and Simulation Working Group.
  21. David Khan: EMA Modelling and Simulation Working Group.
  22. Flora Tshinanu Musuamba: EMA Modelling and Simulation Working Group.
  23. Ine Skottheim Rusten: EMA Modelling and Simulation Working Group.
PMID: 28653481 DOI: 10.1002/psp4.12223

Abstract

During the last 10 years the European Medicines Agency (EMA) organized a number of workshops on modeling and simulation, working towards greater integration of modeling 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 expertise to be able to review M&S data provided by companies in their dossier. This led to the establishment of the EMA Modelling and Simulation Working Group (MSWG). Also, there was agreement reached on the need for harmonization on good M&S practices and for continuing dialog 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.

References

  1. Clin Pharmacol Ther. 2015 Mar;97(3):247-62 [PMID: 25670209]
  2. CPT Pharmacometrics Syst Pharmacol. 2016 Mar;5(3):93-122 [PMID: 27069774]
  3. J Pharmacokinet Pharmacodyn. 2015 Jun;42(3):301-14 [PMID: 25925797]
  4. CPT Pharmacometrics Syst Pharmacol. 2017 Feb;6(2):87-109 [PMID: 27884052]
  5. CPT Pharmacometrics Syst Pharmacol. 2015 Oct;4(10):565-75 [PMID: 26535157]
  6. CPT Pharmacometrics Syst Pharmacol. 2013 Jul 03;2:e51 [PMID: 23836283]

Grants

  1. MR/M008665/1/Medical Research Council

MeSH Term

Computer Simulation
Drug Discovery
Drug Industry
Europe
Models, Theoretical
Journal Article
Article has an altmetric score of 1

Word Cloud

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