Drug Development Process: Nonclinical Development of Small-Molecule Drugs

This article provides a high-level overview of the drug development process of small-molecule drugs for the analytical chemist. Emphasis is given to the nonclinical development and roles of the technical development organization in driving the new drug development project from toxicology studies to new product registration. A case study of the career path of a separation scientist is used to illustrate the diversified roles of an analytical chemist in drug development.