Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation
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- SF Marshall
- Pharmacometrics Pfizer Ltd Sandwich UK
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- R Burghaus
- Systems Pharmacology & Medicine Bayer Pharma AG Wuppertal Germany
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- V Cosson
- Clinical Pharmacometrics F. Hoffmann‐La Roche Ltd Basel Switzerland
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- SYA Cheung
- Quantitative Clinical Pharmacology AstraZeneca Cambridge UK
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- M Chenel
- Institut de Recherches Internationales Servier Suresnes France
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- O DellaPasqua
- Clinical Pharmacology Modelling & Simulation GlaxoSmithKline R&D Ltd Uxbridge UK
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- N Frey
- Clinical Pharmacometrics F. Hoffmann‐La Roche Ltd Basel Switzerland
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- B Hamrén
- Quantitative Clinical Pharmacology AstraZeneca Gothenburg Sweden
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- L Harnisch
- Pharmacometrics Pfizer Ltd Sandwich UK
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- F Ivanow
- Global regulatory policy & Intelligence Janssen R&D High Wycombe UK
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- T Kerbusch
- Quantitative Pharmacology & Pharmacometrics MSD Oss Netherlands
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- J Lippert
- Systems Pharmacology & Medicine Bayer Pharma AG Wuppertal Germany
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- PA Milligan
- Pharmacometrics Pfizer Ltd Sandwich UK
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- S Rohou
- Global Regulatory Affairs & Policy AstraZeneca Paris France
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- A Staab
- Translational Medicine & Clinical Pharmacology Boehringer Ingelheim Pharma GmbH & Co. KG Biberach Germany
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- JL Steimer
- Pharmacometrics Novartis Basel CH
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- C Tornøe
- Clinical Reporting Novo Nordisk A/S Søborg Denmark
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- SAG Visser
- Quantitative Pharmacology & Pharmacometrics Merck & Co Kenilworth USA
説明
<jats:p>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 <jats:bold>company decision makers</jats:bold> how the strategic integration of MID3 can benefit R&D efficiency; ii) provide <jats:bold>MID3 analysts</jats:bold> with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide <jats:bold>regulatory authorities</jats:bold> with substrate to develop MID3 related and/or MID3 enabled guidelines.</jats:p>
収録刊行物
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- CPT: Pharmacometrics & Systems Pharmacology
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CPT: Pharmacometrics & Systems Pharmacology 5 (3), 93-122, 2016-03
Wiley