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

被引：264

作者：

Marshall, S. F. ^{[1
]}

Burghaus, R. ^{[2
]}

Cosson, V. ^{[3
]}

Cheung, S. Y. A. ^{[4
]}

Chenel, M. ^{[5
]}

DellaPasqua, O. ^{[6
]}

Frey, N. ^{[3
]}

Hamren, B. ^{[7
]}

Harnisch, L. ^{[1
]}

Ivanow, F. ^{[8
]}

Kerbusch, T. ^{[9
]}

Lippert, J. ^{[2
]}

Milligan, P. A. ^{[1
]}

Rohou, S. ^{[10
]}

Staab, A. ^{[11
]}

Steimer, J. L. ^{[12
]}

Tornoe, C. ^{[13
]}

Visser, S. A. G. ^{[14
]}

机构：

[1] Pfizer Ltd, Pharmacometr, Sandwich, Kent, England

[2] Bayer Pharma AG, Syst Pharmacol & Med, Wuppertal, Germany

[3] F Hoffmann La Roche Ltd, Clin Pharmacometr, Basel, Switzerland

[4] AstraZeneca, Quantitat Clin Pharmacol, Cambridge, England

[5] Servier, Inst Rech Int, Suresnes, France

[6] GlaxoSmithKline Res & Dev Ltd, Clin Pharmacol Modelling & Simulat, Uxbridge, Middx, England

[7] AstraZeneca, Quantitat Clin Pharmacol, Gothenburg, Sweden

[8] Janssen R&D, Global Regulatory Policy & Intelligence, High Wycombe, Bucks, England

[9] MSD, Quantitat Pharmacol & Pharmacometr, Oss, Netherlands

[10] AstraZeneca, Global Regulatory Affairs & Policy, Paris, France

[11] Boehringer Ingelheim Pharma GmbH & Co KG, Translat Med & Clin Pharmacol, Biberach, Germany

[12] Novartis, Pharmacometr, Basel, Switzerland

[13] Novo Nordisk AS, Clin Reporting, Soborg, Denmark

[14] Merck & Co Inc, Quantitat Pharmacol & Pharmacometr, Kenilworth, NJ USA

来源：

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY | 2016年 / 5卷 / 03期

关键词：

D O I：

10.1002/psp4.12049

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：93 / 122

页数：30

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