UNIT 10.3 Toxicology in the Drug Discovery and Development Process

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

Published Online: 1 MAY 2001

DOI: 10.1002/0471141755.ph1003s02

Current Protocols in Pharmacology

Current Protocols in Pharmacology

How to Cite

Dorato, M. A. and Buckley, L. A. 2001. Toxicology in the Drug Discovery and Development Process. Current Protocols in Pharmacology. 10:10.3.

Author Information

  1. Lilly Research Laboratories, Indianapolis, Indiana

Publication History

  1. Published Online: 1 MAY 2001
  2. Published Print: SEP 1998

This is not the most recent version of the article. View current version (1 APR 2006)


The primary objective of toxicology studies in the drug development process is to evaluate the safety of potential drug candidates using relevant animal models and validated procedures. The ultimate goal is to interpret the animal data to assess risk for human subjects/patients. Therefore, the toxicologist must be aware of the international guidelines for safety evaluation in conjunction with the use of traditional and nontraditional models such as transgenic animals. This overview discusses the components of a typical toxicology profile including 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. (Due to the wide variety of therapeutic targets, toxicology profiles may differ from drug to drug.) Also, regulatory guidelines for toxicology testing are explained in relation to the drug discovery and development process.