UNIT 10.3 Toxicology in the Drug Discovery and Development Process

  1. Michael A. Dorato,
  2. Lorrene A. Buckley

Published Online: 1 APR 2006

DOI: 10.1002/0471141755.ph1003s32

Current Protocols in Pharmacology

Current Protocols in Pharmacology

How to Cite

Dorato, M. A. and Buckley, L. A. 2006. Toxicology in the Drug Discovery and Development Process. Current Protocols in Pharmacology. 32:10.3:10.3.1–10.3.35.

Author Information

  1. Lilly Research Laboratories, Greenfield, Indiana

Publication History

  1. Published Online: 1 APR 2006
  2. Published Print: MAR 2006


The primary objective of toxicology studies in the drug development process is to evaluate the safety of potential drug candidates. This is accomplished using relevant animal models and validated procedures. The ultimate goal is to translate the animal model responses into an understanding of the risk for human subjects. To this end, the toxicologist must be aware of the international guidelines for safety evaluation, as well as traditional and nontraditional toxicology models. As described in this unit, the typical toxicology profile consists of safety pharmacology, genetic toxicology, acute and subchronic toxicology, chronic toxicology, absorption, distribution, metabolism, and excretion (ADME) studies, reproductive and developmental toxicology, and an evaluation of carcinogenic potential.


  • Drug discovery and development process;
  • International regulatory approaches;
  • International Harmonization, Toxicology Profiles