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=<p>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).</p>