Micro-CT as a new method for assessing non-clinical skeletal birth defects
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Developmental toxicity testing is important non-clinical testing for the development of new drugs and is generally conducted based on the International Conference on Harmonization guidelines S5 (R3). Skeletal birth defect examinations in developmental toxicity testing are an important endpoint for the observation of fetal structural alterations. Currently, alizarin red and/or alcian blue staining is considered the gold standard for evaluating fetal bone structure. However, these staining methods have several limitations, including time consumption, potential loss, artifacts, limited additional analyses, and space for archiving. Micro-computed tomography (micro-CT) scanning for skeletal birth defects has emerged as an alternate method to resolve the limitations and concerns of the current staining methods. This review provides an overview of micro-CT methods for the examination of skeletal birth defects, including procedures, advantages, applied examples, limitations, and future directions for regulatory acceptance. With advancements in technology, micro-CT for skeletal birth defect examinations could be more widely used in future developmental toxicity testing. Adopting this new technology will reduce the number of animals, labor, and time used in non-clinical toxicity tests.
Abstract
Developmental toxicity testing is important non-clinical testing for the development of new drugs and is generally conducted based on the International Conference on Harmonization guidelines S5 (R3). Skeletal birth defect examinations in developmental toxicity testing are an important endpoint for the observation of fetal structural alterations. Currently, alizarin red and/or alcian blue staining is considered the gold standard for evaluating fetal bone structure. However, these staining methods have several limitations, including time consumption, potential loss, artifacts, limited additional analyses, and space for archiving. Micro-computed tomography (micro-CT) scanning for skeletal birth defects has emerged as an alternate method to resolve the limitations and concerns of the current staining methods. This review provides an overview of micro-CT methods for the examination of skeletal birth defects, including procedures, advantages, applied examples, limitations, and future directions for regulatory acceptance. With advancements in technology, micro-CT for skeletal birth defect examinations could be more widely used in future developmental toxicity testing. Adopting this new technology will reduce the number of animals, labor, and time used in non-clinical toxicity tests.
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