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Toxicological Considerations for Pharmaceutical Products

Toxicology of Specific Groups of Substances

  1. Lynnda Reid PhD Pharmacology/Toxicology Supervisor

Published Online: 15 DEC 2009

DOI: 10.1002/9780470744307.gat115

General, Applied and Systems Toxicology

General, Applied and Systems Toxicology

How to Cite

Reid, L. 2009. Toxicological Considerations for Pharmaceutical Products. General, Applied and Systems Toxicology. .

Author Information

  1. Center for Drug Evaluation and Research, Division of Reproductive and Urologic Products, US Food and Drug Administration, Silver Spring, Maryland, USA

Publication History

  1. Published Online: 15 DEC 2009

Abstract

This chapter is designed to highlight some of the general toxicologic concepts, for example species selection, duration and dosing, which should be taken into consideration when designing a nonclinical investigatory programme intended to support development of pharmaceutical agents. The extent and types of studies needed as well as their timing relevant to the stage of clinical development are discussed. For questions regarding nonclinical development programmes for specific products, regional regulatory agencies should be consulted.

Keywords:

  • nonclinical;
  • pharmaceutical;
  • medicinal;
  • drug;
  • regulatory toxicology;
  • ICH