Toxicological Considerations for Pharmaceutical Products

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