Regulatory Forum Opinion Piece*: Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey
| Autor: | Monicah A. Otieno, Peggy Guzzie-Peck, Thomas W. Jones, Robert J Schulingkamp, Sherry J. Morgan, Ray Kemper, Douglas A. Keller, Jessica Couch |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Toxicology testing medicine.medical_specialty business.industry Nonclinical safety Survey result Cell Biology Disease Pharmacology Toxicology Focus group Opinion piece Pathology and Forensic Medicine 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Drug development Family medicine Medicine business Molecular Biology 030217 neurology & neurosurgery Pharmaceutical industry |
| Zdroj: | Toxicologic Pathology. 45:372-380 |
| ISSN: | 1533-1601 0192-6233 |
| DOI: | 10.1177/0192623317701004 |
| Popis: | An Innovation and Quality (IQ) Consortium focus group conducted a cross-company survey to evaluate current practices and perceptions around the use of animal models of disease (AMDs) in nonclinical safety assessment of molecules in clinical development. The IQ Consortium group is an organization of pharmaceutical and biotechnology companies with the mission of advancing science and technology. The survey queried the utilization of AMDs during drug discovery in which drug candidates are evaluated in efficacy models and limited short-duration non-Good Laboratory Practices (GLP) toxicology testing and during drug development in which drug candidates are evaluated in GLP toxicology studies. The survey determined that the majority of companies used AMDs during drug discovery primarily as a means for proactively assessing potential nonclinical safety issues prior to the conduct of toxicology studies, followed closely by the use of AMDs to better understand toxicities associated with exaggerated pharmacology in traditional toxicology models or to derisk issues when the target is only expressed in the disease state. In contrast, the survey results indicated that the use of AMDs in development is infrequent, being used primarily to investigate nonclinical safety issues associated with targets expressed only in disease states and/or in response to requests from global regulatory authorities. |
| Databáze: | OpenAIRE |
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