Open AccessGood Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation
Author(s) -
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
Publication year - 2016
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12049
Subject(s) - documentation , consistency (knowledge bases) , process management , quality (philosophy) , good manufacturing practice , best practice , knowledge management , computer science , business , political science , marketing , philosophy , epistemology , artificial intelligence , law , programming language , supply chain
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.