title: ICH guidelines: inception, revision, and implications for drug development.
authors.affiliation: Preclinical Safety, Novartis Pharmaceuticals Corporation, Emeryville, California 94608, USA. tao.wang@novartis.com
authors.forename: Tao
authors.initials: T
authors.lastname: Wang
authors.forename: David
authors.initials: D
authors.lastname: Jacobson-Kram
authors.forename: Anne M
authors.initials: AM
authors.lastname: Pilaro
authors.forename: Daniel
authors.initials: D
authors.lastname: Lapadula
authors.forename: Abigail
authors.initials: A
authors.lastname: Jacobs
authors.forename: Paul
authors.initials: P
authors.lastname: Brown
authors.forename: John
authors.initials: J
authors.lastname: Lipscomb
authors.forename: William David
authors.initials: WD
authors.lastname: McGuinn
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000494:pharmacology; D001688:Biological Products / Q000633:toxicity; D001709:Biotechnology / Q000379:methods; D015195:Drug Design; D055808:Drug Discovery; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies / Q000458:organization & administration*; D007391:International Cooperation; D009152:Mutagenicity Tests; D012098:Reproduction / Q000187:drug effects
chemical_list: D000970:Antineoplastic Agents; D001688:Biological Products