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Manolis E, Brogren J, Cole S, et al. Commentary on the MID3 Good Practices Paper. CPT Pharmacometrics Syst Pharmacol. 2017;6(7):416-417doi: 10.1002/psp4.12223.
Manolis, E., Brogren, J., Cole, S., Hay, J. L., Nordmark, A., Karlsson, K. E., Lentz, F., Benda, N., Wangorsch, G., Pons, G., Zhao, W., Gigante, V., Serone, F., Standing, J. F., Dokoumetzidis, A., Vakkilainen, J., van den Heuvel, M., Mangas Sanjuan, V., Taminiau, J., Kerwash, E., Khan, D., Musuamba, F. T., Skottheim Rusten, I. (2017). Commentary on the MID3 Good Practices Paper. CPT: pharmacometrics & systems pharmacology, 6(7), 416-417. https://doi.org/10.1002/psp4.12223
Manolis, Efthymios, et al. "Commentary on the MID3 Good Practices Paper." CPT: pharmacometrics & systems pharmacology vol. 6,7 (2017): 416-417. doi: https://doi.org/10.1002/psp4.12223
Manolis E, Brogren J, Cole S, Hay JL, Nordmark A, Karlsson KE, Lentz F, Benda N, Wangorsch G, Pons G, Zhao W, Gigante V, Serone F, Standing JF, Dokoumetzidis A, Vakkilainen J, van den Heuvel M, Mangas Sanjuan V, Taminiau J, Kerwash E, Khan D, Musuamba FT, Skottheim Rusten I. Commentary on the MID3 Good Practices Paper. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):416-417. doi: 10.1002/psp4.12223. Epub 2017 Jul 22. PMID: 28653481; PMCID: PMC5529732.
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CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):416-417. doi: 10.1002/psp4.12223. Epub 2017 Jul 22.

Commentary on the MID3 Good Practices Paper.

CPT: pharmacometrics & systems pharmacology

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,

Affiliations

  1. European Medicines Agency, London, UK.
  2. EMA Modelling and Simulation Working Group.
  3. Medical Products Agency, Uppsala, Sweden.
  4. Medicines & Healthcare Products Regulatory Agency, London, UK.
  5. Federal Institute for Drugs and Medical Devices, Bonn, Germany.
  6. Paul Ehrlich Institute, Langen (Hessen), Germany.
  7. University Paris-Descartes, Paris, France.
  8. Robert Debre University Hospital of Paris, France.
  9. Shandong University, Jinan, China.
  10. Italian Medicines Agency, Rome, Italy.
  11. University College London, UK.
  12. University of Athens, Greece.
  13. Finnish Medicines Agency, Helsinki, Finland.
  14. Medicines Evaluation Board, Utrecht, Netherlands.
  15. University of Valencia, Valencia, Spain.
  16. Antwerp University Hospital, Antwerp, Netherlands.
  17. Federal Agency for Medicines and Health Products, Brussels, Belgium.
  18. The Norwegian Medicines Agency, Oslo, Norway.

PMID: 28653481 PMCID: PMC5529732 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.

© 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

References

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