Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report.

Autor: Solomon HM; GlaxoSmithKline, King of Prussia, PA, United States., Makris SL; U.S. Environmental Protection Agency, National Center for Environmental Assessment, Washington, DC, United States. Electronic address: makris.susan@epa.gov., Alsaid H; GlaxoSmithKline, King of Prussia, PA, United States., Bermudez O; ILSI Health and Environmental Sciences Institute, Washington, DC, United States., Beyer BK; Sanofi U.S. Inc., Bridgewater, NJ, United States., Chen A; Merck Research Laboratories, Kenilworth, NJ, United States., Chen CL; ILSI Health and Environmental Sciences Institute, Washington, DC, United States., Chen Z; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States., Chmielewski G; Covance Laboratories, Greenfield, IN, United States., DeLise AM; Novartis Pharmaceutical Corporation, East Hanover, NJ, United States., de Schaepdrijver L; Janssen R&D, Beerse, Belgium., Dogdas B; Merck Research Laboratories, Kenilworth, NJ, United States., French J; Morphology Consulting Ltd., Staffordshire, United Kingdom., Harrouk W; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States., Helfgott J; Stage 2 Innovations, Framingham, MI, United States., Henkelman RM; The Hospital for Sick Children, University of Toronto, Toronto, Canada., Hesterman J; InviCRO, Boston, MA, United States., Hew KW; Takeda Pharmaceutical Company, Deerfield, IL, United States., Hoberman A; Charles River Laboratories, Preclinical Services, Horsham, PA, United States., Lo CW; University of Pittsburgh, Pittsburgh, PA, United States., McDougal A; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States., Minck DR; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, United States., Scott L; Charles River Laboratories, Preclinical Services, Horsham, PA, United States., Stewart J; ApconiX, Macclesfield, Cheshire, United Kingdom., Sutherland V; National Toxicology Program/NIEHS, Research Triangle Park, NC, United States., Tatiparthi AK; Covance Laboratories, Greenfield, IN, United States., Winkelmann CT; Pfizer Worldwide Research & Development, La Jolla, CA, United States., Wise LD; Independent Teratologist, Philadelphia, PA, United States., Wood SL; Merck Research Laboratories, Upper Gwynedd, PA, United States., Ying X; Sanofi U.S. Inc., Cambridge, MA, United States.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2016 Jun; Vol. 77, pp. 100-8. Date of Electronic Publication: 2016 Feb 27.
DOI: 10.1016/j.yrtph.2016.02.018
Abstrakt: During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies. Implementing these technologies into the Good Laboratory Practice environment requires rigorous testing, validation, and documentation to ensure the reproducibility of data. A workshop on current practices and regulatory requirements was held with the goal of defining minimal criteria for the proper implementation of these technologies and subsequent submission to regulatory agencies. Micro-computed tomography (micro-CT) is especially well suited for high-throughput evaluations, and is gaining popularity to evaluate fetal skeletons to assess the potential developmental toxicity of test agents. This workshop was convened to help scientists in the developmental toxicology field understand and apply micro-CT technology to nonclinical toxicology studies and facilitate the regulatory acceptance of imaging data. Presentations and workshop discussions covered: (1) principles of micro-CT fetal imaging; (2) concordance of findings with conventional skeletal evaluations; and (3) regulatory requirements for validating the system. Establishing these requirements for micro-CT examination can provide a path forward for laboratories considering implementing this technology and provide regulatory agencies with a basis to consider the acceptability of data generated via this technology.
(Published by Elsevier Inc.)
Databáze: MEDLINE
Externí odkaz: