Cited by 373Pharmaceutical studies and practicesStatistical Methods in Clinical TrialsPharmacogenetics and Drug Metabolism

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

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EFPIA MID3 Workgroup, Marshall, SF, Burghaus, R, Cosson, V, Cheung, SYA, Chenel, M, DellaPasqua, O, Frey, N, Hamrén, B, Harnisch, L, Ivanow, F, Kerbusch, T, Lippert, J, Milligan, PA, Rohou, S, Staab, A, Steimer, JL, Tornøe, C, Visser, SAG·2016·CPT: Pharmacometrics & Systems Pharmacology

DOI 10.1002/psp4.12049PMC PMC4809625

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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.

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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
ORCID: Burghaus, R
Cosson, V
Cheung, SYA
Chenel, M
Frey, N
Hamrén, B
Harnisch, L
Kerbusch, T
Lippert, J
Venue: CPT: Pharmacometrics & Systems Pharmacology
Publisher: Wiley
Published: 2016-03
Volume: 5
Issue: 3
Pages: 93-122
ISSN: 2163-8306 (ISSN-L)
DOI: 10.1002/psp4.12049
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: cc-by-nc
creativecommons.org/licenses/by-nc/4.0/ (vor, 13 d)
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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Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation

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