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Regul Toxicol Pharmacol ; 77: 100-8, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-26930635

RESUMO

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.


Assuntos
Anormalidades Induzidas por Medicamentos/diagnóstico por imagem , Osso e Ossos/diagnóstico por imagem , Biologia do Desenvolvimento/métodos , Feto/diagnóstico por imagem , Testes de Toxicidade/métodos , Microtomografia por Raio-X , Animais , Osso e Ossos/anormalidades , Osso e Ossos/efeitos dos fármacos , Consenso , Biologia do Desenvolvimento/normas , Feto/anormalidades , Feto/efeitos dos fármacos , Guias como Assunto , Humanos , Variações Dependentes do Observador , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Testes de Toxicidade/normas , Microtomografia por Raio-X/normas
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