title: Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.
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.
authors.affiliation: Pharmacometrics Pfizer Ltd Sandwich UK.
authors.forename: S F
authors.initials: SF
authors.lastname: Marshall
authors.affiliation: Systems Pharmacology & Medicine Bayer Pharma AG Wuppertal Germany.
authors.forename: R
authors.initials: R
authors.lastname: Burghaus
authors.affiliation: Clinical Pharmacometrics F. Hoffmann-La Roche Ltd Basel Switzerland.
authors.forename: V
authors.initials: V
authors.lastname: Cosson
authors.affiliation: Quantitative Clinical Pharmacology AstraZeneca Cambridge UK.
authors.forename: S Y A
authors.initials: SY
authors.lastname: Cheung
authors.affiliation: Institut de Recherches Internationales Servier Suresnes France.
authors.forename: M
authors.initials: M
authors.lastname: Chenel
authors.affiliation: Clinical Pharmacology Modelling & Simulation GlaxoSmithKline R&D Ltd Uxbridge UK.
authors.forename: O
authors.initials: O
authors.lastname: DellaPasqua
authors.affiliation: Clinical Pharmacometrics F. Hoffmann-La Roche Ltd Basel Switzerland.
authors.forename: N
authors.initials: N
authors.lastname: Frey
authors.affiliation: Quantitative Clinical Pharmacology AstraZeneca Gothenburg Sweden.
authors.forename: B
authors.initials: B
authors.lastname: Hamrén
authors.affiliation: Pharmacometrics Pfizer Ltd Sandwich UK.
authors.forename: L
authors.initials: L
authors.lastname: Harnisch
authors.affiliation: Global regulatory policy & Intelligence Janssen R&D High Wycombe UK.
authors.forename: F
authors.initials: F
authors.lastname: Ivanow
authors.affiliation: Quantitative Pharmacology & Pharmacometrics MSD Oss Netherlands.
authors.forename: T
authors.initials: T
authors.lastname: Kerbusch
authors.affiliation: Systems Pharmacology & Medicine Bayer Pharma AG Wuppertal Germany.
authors.forename: J
authors.initials: J
authors.lastname: Lippert
authors.affiliation: Pharmacometrics Pfizer Ltd Sandwich UK.
authors.forename: P A
authors.initials: PA
authors.lastname: Milligan
authors.affiliation: Global Regulatory Affairs & Policy AstraZeneca Paris France.
authors.forename: S
authors.initials: S
authors.lastname: Rohou
authors.affiliation: Translational Medicine & Clinical Pharmacology Boehringer Ingelheim Pharma GmbH & Co. KG Biberach Germany.
authors.forename: A
authors.initials: A
authors.lastname: Staab
authors.affiliation: Pharmacometrics Novartis Basel CH.
authors.forename: J L
authors.initials: JL
authors.lastname: Steimer
authors.affiliation: Clinical Reporting Novo Nordisk A/S Søborg Denmark.
authors.forename: C
authors.initials: C
authors.lastname: Tornøe
authors.affiliation: Quantitative Pharmacology & Pharmacometrics Merck & Co Kenilworth USA.
authors.forename: S A G
authors.initials: SA
authors.lastname: Visser
mesh_terms: D004282:Documentation; D015195:Drug Design; D017408:Guidelines as Topic; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards*