Toxicological Considerations for Pharmaceutical Products
Published Online: 15 DEC 2009
Copyright © 2009 John Wiley & Sons, Ltd. All rights reserved.
General, Applied and Systems Toxicology
How to Cite
Reid, L. 2009. Toxicological Considerations for Pharmaceutical Products. General, Applied and Systems Toxicology.
- Published Online: 15 DEC 2009
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