Report: Developing criteria for examining fetal skeletons in regulatory developmental tox. studies

Teratology Society members Howard M. Solomon, Susan L. Makris, Bruce K. Beyer, Connie L. Chen, Gary Chmielewski, Anthony M. DeLise, Luc de Schaepdrijver, Julian French, Wafa Harrouk, Kok-Wah Hew, Alan Hoberman, Daniel R. Minck, Jane Stewart, Vicki Sutherland, L. David Wise, Sandra L. Wood, are among the authors of "Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies: A workshop report," published in Regulatory Toxicology and Pharmacology (Volume 77, June 2016, Pages 100–108) based on ILSI HESI hosted workshop that took place in April 2016.

ABSTRACT: 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.

Full paper available HERE.

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