AUTHOR=Kondic Anna , Bottino Dean , Harrold John , Kearns Jeffrey D. , Musante CJ , Odinecs Aleksandrs , Ramanujan Saroja , Selimkhanov Jangir , Schoeberl Birgit TITLE=Navigating Between Right, Wrong, and Relevant: The Use of Mathematical Modeling in Preclinical Decision Making JOURNAL=Frontiers in Pharmacology VOLUME=13 YEAR=2022 URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.860881 DOI=10.3389/fphar.2022.860881 ISSN=1663-9812 ABSTRACT=

The goal of this mini-review is to summarize the collective experience of the authors for how modeling and simulation approaches have been used to inform various decision points from discovery to First-In-Human clinical trials. The article is divided into a high-level overview of the types of problems that are being aided by modeling and simulation approaches, followed by detailed case studies around drug design (Nektar Therapeutics, Genentech), feasibility analysis (Novartis Pharmaceuticals), improvement of preclinical drug design (Pfizer), and preclinical to clinical extrapolation (Merck, Takeda, and Amgen).