Details

Autor(en) / Beteiligte

• 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

Titel

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

Ist Teil von

• CPT: pharmacometrics and systems pharmacology, 2016-03, Vol.5 (3), p.93-122

Ort / Verlag

United States: John Wiley & Sons, Inc

Erscheinungsjahr

2016

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• 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.