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Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation
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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.
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Metadata
- Authors
- Workgroup, E. M., Marshall, S., Burghaus, R., Cosson, V, Cheung, S., Chenel, M., DellaPasqua, O., Frey, N., Hamrén, B., Harnisch, L., Ivanow, F., Kerbusch, T., Lippert, J., Milligan, P., Rohou, S., Staab, A., Steimer, J., Tornøe, C., & Visser, S.
- Affiliations
- Pfizer (United Kingdom) (GB)
- F. Hoffmann-La Roche AG (CH)
- AstraZeneca (United Kingdom) (GB)
- GlaxoSmithKline (United Kingdom) (GB)
- Clinical Pharmacology Modelling & Simulation GlaxoSmithKline R&D Ltd Uxbridge UK
- Janssen (United Kingdom) (GB)
- MSD (Netherlands) (NL)
- Pharmacometrics Pfizer Ltd Sandwich UK
- Global Regulatory Affairs & Policy AstraZeneca Paris France
- Novartis (Switzerland) (CH)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Quantitative Pharmacology & Pharmacometrics Merck & Co Kenilworth USA
- Corresponding author
- Marshall, SF
- Venue
- CPT: Pharmacometrics & Systems Pharmacology
- Publisher
- Wiley
- Published
- 2016-03
- Volume
- 5
- Issue
- 3
- Pages
- 93-122
- ISSN
- 2163-8306 (ISSN-L)
- PMC
- PMC4809625
- OpenAlex
- W2181278642
- Cited by
- 373
- References
- 82
- Citations by year
- 2026: 26 · 2025: 44 · 2024: 37 · 2023: 36 · 2022: 32 · 2021: 51 · 2020: 38 · 2019: 40 · 2018: 33 · 2017: 22 · 2016: 12
- FWCI
- 22.58
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- CPT Pharmacometrics & Systems Pharmacology (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- good practice recommendations, pharmacokinetic-pharmacodynamic modeling, R&D efficiency, regulatory guidelines, pharmaceutical industry
- MeSH terms
- Documentation, Technology, Pharmaceutical, Drug Design, Guidelines as Topic
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