title: Changes to ICH guideline M3: new and revised guidance on nonclinical safety studies to support human clinical trials and marketing authorization.
authors.affiliation: Department of Safety Assessment & Laboratory Animal Resources, Merck Research Laboratories, West Point, Pennsylvania, USA.
authors.forename: B J
authors.initials: BJ
authors.lastname: Ledwith
authors.forename: J J
authors.initials: JJ
authors.lastname: DeGeorge
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D003226:Congresses as Topic / Q000592:standards*; D004338:Drug Combinations; D055808:Drug Discovery; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007390:International Agencies; D007391:International Cooperation; D008389:Marketing of Health Services / Q000592:standards*; D018675:Toxicity Tests / Q000592:standards; D057170:Translational Research, Biomedical
chemical_list: D004338:Drug Combinations