Commentary on the MID3 Good Practices Paper

Author:

Manolis Efthymios12,Brogren Jacob23,Cole Susan24,Hay Justin L.24,Nordmark Anna23,Karlsson Kristin E.23,Lentz Frederike25,Benda Norbert25,Wangorsch Gaby26,Pons Gerard27,Zhao Wei289,Gigante Valeria210,Serone Francesca210,Standing Joseph F.211,Dokoumetzidis Aris212,Vakkilainen Juha213,van den Heuvel Michiel214,Mangas Sanjuan Victor215,Taminiau Johannes216,Kerwash Essam24,Khan David23,Musuamba Flora Tshinanu217,Skottheim Rusten Ine218,

Affiliation:

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

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Reference9 articles.

1. Good practices in model-informed drug discovery and development: Practice, application, and documentation;EFPIA MID3 Workgroup;CPT Pharmacometrics Syst. Pharmacol.,2016

2. Establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance;Byon;CPT Pharmacometrics Syst. Pharmacol.

3. Reporting guidelines for population pharmacokinetic analyses;Dykstra;J. Pharmacokinet. Pharmacodyn.,2015

4. Establishing good practices for exposure-response analysis of clinical endpoints in drug development;Overgaard;CPT Pharmacometrics Syst. Pharmacol.,2015

5. Model Evaluation Group of the International Society of Pharmacometrics ISoP Best Practice Committee. Model evaluation of continuous data pharmacometric models: Metrics and graphics;Nguyen;CPT Pharmacometrics Syst. Pharmacol.,2016

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