Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices

Accurate determination of therapeutic indices from nonclinical studies across multiple species provides an invaluable tool for advancing compounds with reduced potential for harm and reduced likelihood of attrition for safety concerns. The robustness of those estimates over time is also central to the ability to conduct proof-of-concept studies in humans in phases IIa and IIb. This article focuses on novel and traditional nonclinical biomarker utilization in the estimation of pharmaceutical therapeutic indices. Keywords: nonclinical studies; therapeutic indices; pharmaceuticals