title: Use of animals for toxicology testing is necessary to ensure patient safety in pharmaceutical development.
abstract: There is an active debate in toxicology literature about the utility of animal testing vis-a-vis alternative in vitro paradigms. To provide a balanced perspective and add to this discourse it is important to review the current paradigms, explore pros and cons of alternatives, and provide a vision for the future. The fundamental goal of toxicity testing is to ensure safety in humans. In this article, IQ Consortium DruSafe, while submitting the view that nonclinical testing in animals is an important and critical component of the risk assessment paradigm in developing new drugs, also discusses its views on alternative approaches including a roadmap for what would be required to enhance the utilization of alternative approaches in the safety assessment process.
authors: Bristol-Myers Squibb, New Brunswick, New Jersey, 1 Squibb Drive, New Brunswick, NJ 08903, United States. Electronic address: raja.mangipudy@bms.com.
authors: Raja
authors: R
authors: Mangipudy
authors: AbbVie, Preclinical Safety, 1 North Waukegan Road, R46G, North Chicago, IL 60044, United States.
authors: John
authors: J
authors: Burkhardt
authors: BluePrint Medicines, Nonclinical Development, 215 First Street Cambridge, MA 02142, United States.
authors: Vivek J
authors: VJ
authors: Kadambi
mesh_terms: D000826:Animal Testing Alternatives / Q000379:methods*; D000818:Animals; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D061214:Patient Safety; D018570:Risk Assessment / Q000379:methods; D018675:Toxicity Tests / Q000941:ethics / Q000379:methods*
keywords: 3Rs; DruSafe; In vivo toxicology testing; Predictivity