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CPT Pharmacometrics Syst Pharmacol. 2016 Mar;5(3):93-122. doi: 10.1002/psp4.12049. Epub 2016 Mar 14.

Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.

Author information

1
Pharmacometrics Pfizer Ltd Sandwich UK.
2
Systems Pharmacology & Medicine Bayer Pharma AG Wuppertal Germany.
3
Clinical Pharmacometrics F. Hoffmann-La Roche Ltd Basel Switzerland.
4
Quantitative Clinical Pharmacology AstraZeneca Cambridge UK.
5
Institut de Recherches Internationales Servier Suresnes France.
6
Clinical Pharmacology Modelling & Simulation GlaxoSmithKline R&D Ltd Uxbridge UK.
7
Quantitative Clinical Pharmacology AstraZeneca Gothenburg Sweden.
8
Global regulatory policy & Intelligence Janssen R&D High Wycombe UK.
9
Quantitative Pharmacology & Pharmacometrics MSD Oss Netherlands.
10
Global Regulatory Affairs & Policy AstraZeneca Paris France.
11
Translational Medicine & Clinical Pharmacology Boehringer Ingelheim Pharma GmbH & Co. KG Biberach Germany.
12
Pharmacometrics Novartis Basel CH.
13
Clinical Reporting Novo Nordisk A/S Søborg Denmark.
14
Quantitative Pharmacology & Pharmacometrics Merck & Co Kenilworth USA.

Abstract

This document was developed to enable greater consistency in the practice, application, and documentation of Model-Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of "good practice" recommendations are assembled here in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of this white paper are to: i) inform company decision makers how the strategic integration of MID3 can benefit R&D efficiency; ii) provide MID3 analysts with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide regulatory authorities with substrate to develop MID3 related and/or MID3 enabled guidelines.

PMID:
27069774
PMCID:
PMC4809625
DOI:
10.1002/psp4.12049
[Indexed for MEDLINE]
Free PMC Article

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