title: Toxicology in the drug discovery and development process.
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.
authors.affiliation: Lilly Research Laboratories, Greenfield, Indiana, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Dorato
authors.forename: Lorrene A
authors.initials: LA
authors.lastname: Buckley
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000517:prevention & control; D000818:Animals; D001709:Biotechnology / Q000379:methods / Q000639:trends; D002986:Clinical Trials as Topic; D004195:Disease Models, Animal; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval / Q000379:methods; D055808:Drug Discovery / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D006801:Humans; D020714:Maximum Tolerated Dose; D008954:Models, Biological; D009152:Mutagenicity Tests; D009153:Mutagens / Q000009:adverse effects; D019055:No-Observed-Adverse-Effect Level; D010599:Pharmacokinetics; D017410:Practice Guidelines as Topic; D011994:Recombinant Proteins; D060728:Reproductive Health; D013045:Species Specificity; D013678:Technology, Pharmaceutical / Q000379:methods / Q000639:trends; D014116:Toxicology / Q000379:methods*
chemical_list: D009153:Mutagens; D011994:Recombinant Proteins