Open AccessModel‐Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives
Author(s) -
Marshall Scott,
Madabushi Rajanikanth,
Manolis Efthymios,
Krudys Kevin,
Staab Alexander,
Dykstra Kevin,
Visser Sandra A.G.
Publication year - 2019
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/psp4.12372
Subject(s) - standardization , regulatory science , drug development , agency (philosophy) , regulatory agency , guideline , food and drug administration , regulatory authority , business , pharmaceutical industry , engineering ethics , public relations , medicine , risk analysis (engineering) , drug , political science , pharmacology , public administration , engineering , philosophy , epistemology , pathology , law
Good practices around model‐informed drug discovery and development (MID3) aim to improve the implementation, standardization, and acceptance of these approaches within drug development and regulatory review. A survey targeted to clinical pharmacology and pharmacometric colleagues across industry, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) was conducted to understand current and future roles of MID3. The documented standards were generally affirmed as a “good match” to current industry practice and regulatory expectations, with some identified gaps that are discussed. All have seen at least a “modest” step forward in MID3 implementation associated with greater organizational awareness and share the expectation for a future wider use and impact. The priority within organizations was identified as a limitation with respect to the future of MID3. Finally, potential solutions, including a global overarching MID3 regulatory guideline, to facilitate greater acceptance by industry and regulatory decision makers are discussed.