Curr Protoc Pharmacol. 2006 Apr;Unit10.3. doi: 10.1002/0471141755.ph1003s32.

Toxicology in the drug discovery and development process.

Current protocols in pharmacology

Michael A Dorato, Lorrene A Buckley

PMID: 22294168 DOI: 10.1002/0471141755.ph1003s32

Abstract

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.

Substances

• Mutagens
• Recombinant Proteins

MeSH terms

• Abnormalities, Drug-Induced / prevention & control
• Animals
• Biotechnology / methods
• Biotechnology / trends
• Clinical Trials as Topic
• Disease Models, Animal
• Dose-Response Relationship, Drug
• Drug Approval / methods
• Drug Discovery / methods
• Drug Evaluation, Preclinical / methods
• Drug-Related Side Effects and Adverse Reactions* / prevention & control
• Humans
• Maximum Tolerated Dose
• Models, Biological
• Mutagenicity Tests
• Mutagens / adverse effects
• No-Observed-Adverse-Effect Level
• Pharmacokinetics
• Practice Guidelines as Topic
• Recombinant Proteins
• Reproductive Health
• Species Specificity
• Technology, Pharmaceutical / methods
• Technology, Pharmaceutical / trends
• Toxicology / methods

Publication Types

• Journal Article