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 Musuamba Tshinanu; Ine Skottheim Rusten

doi:10.1002/psp4.12223

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 KerwashDavid Khan, Flora Musuamba Tshinanu, Ine Skottheim Rusten

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Résumé

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.

langue originale	Anglais
Pages (de - à)	416-417
Nombre de pages	2
journal	CPT: Pharmacometrics and Systems Pharmacology
Volume	6
Numéro de publication	7
Les DOIs	https://doi.org/10.1002/psp4.12223
Etat de la publication	Publié - juil. 2017
Modification externe	Oui

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10.1002/psp4.12223

CPT Pharmacom Syst Pharma - 2017 - Manolis - Commentary on the MID3 Good Practices PaperVersion finale publiée, 56,3 KB

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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., Sanjuan, V. M., Taminiau, J., ... Rusten, I. S. (2017). Commentary on the MID3 good practices paper. CPT: Pharmacometrics and Systems Pharmacology, 6(7), 416-417. https://doi.org/10.1002/psp4.12223

@article{c7625940c69d4b0386a0be717481750b,

title = "Commentary on the MID3 good practices paper",

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.",

author = "Efthymios Manolis and Jacob Brogren and Susan Cole and Hay, {Justin L.} and Anna Nordmark and Karlsson, {Kristin E.} and Frederike Lentz and Norbert Benda and Gaby Wangorsch and Gerard Pons and Wei Zhao and Valeria Gigante and Francesca Serone and Standing, {Joseph F.} and Aris Dokoumetzidis and Juha Vakkilainen and {Van Den Heuvel}, Michiel and Sanjuan, {Victor Mangas} and Johannes Taminiau and Essam Kerwash and David Khan and {Musuamba Tshinanu}, Flora and Rusten, {Ine Skottheim}",

year = "2017",

month = jul,

doi = "10.1002/psp4.12223",

language = "English",

volume = "6",

pages = "416--417",

journal = "CPT: Pharmacometrics and Systems Pharmacology",

issn = "2163-8306",

publisher = "Wiley-Blackwell",

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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, Sanjuan, VM, Taminiau, J, Kerwash, E, Khan, D, Musuamba Tshinanu, F & Rusten, IS 2017, 'Commentary on the MID3 good practices paper', CPT: Pharmacometrics and Systems Pharmacology, VOL. 6, Numéro 7, p. 416-417. https://doi.org/10.1002/psp4.12223

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T1 - Commentary on the MID3 good practices paper

AU - Manolis, Efthymios

AU - Brogren, Jacob

AU - Cole, Susan

AU - Hay, Justin L.

AU - Nordmark, Anna

AU - Karlsson, Kristin E.

AU - Lentz, Frederike

AU - Benda, Norbert

AU - Wangorsch, Gaby

AU - Pons, Gerard

AU - Zhao, Wei

AU - Gigante, Valeria

AU - Serone, Francesca

AU - Standing, Joseph F.

AU - Dokoumetzidis, Aris

AU - Vakkilainen, Juha

AU - Van Den Heuvel, Michiel

AU - Sanjuan, Victor Mangas

AU - Taminiau, Johannes

AU - Kerwash, Essam

AU - Khan, David

AU - Musuamba Tshinanu, Flora

AU - Rusten, Ine Skottheim

PY - 2017/7

Y1 - 2017/7

N2 - 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.

AB - 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.

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JO - CPT: Pharmacometrics and Systems Pharmacology

JF - CPT: Pharmacometrics and Systems Pharmacology

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ER -

Commentary on the MID3 good practices paper

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