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This report discusses the principles of developmental and reproductive toxicity (DART) testing for biopharmaceuticals. Biopharmaceuticals are large‐molecular‐weight proteins or peptides produced by modern biotechnology techniques incorporating genetic engineering and hybridoma technologies....
BACKGROUND: Assessment of developmental toxicity has historically included assessment of fetal skeletal morphology after alizarin red staining. X‐ray micro‐computed tomography (micro‐CT) produces high‐resolution images of skeletal structures and was investigated as an alternative method....
In developmental and reproductive toxicity studies, drinking water is a common means of delivering the test agent. Reduced consumption of toxicant‐containing water raises questions about indirect effects of reduced maternal fluid consumption resulting from unpalatability, versus direct effects...
BACKGROUND: This laboratory has been investigating the utility of X‐ray micro‐computed tomography (micro‐CT) to produce high‐resolution, 3D images of skeletal structures in common laboratory species. The present investigation uses micro‐CT evaluation of skeletons from rabbit fetuses...
BACKGROUND: Angiogenesis plays a key role in embryo–fetal development and, based on nonclinical safety data, the majority of vascular endothelial growth factor (VEGF)‐targeted antiangiogenic agents used in cancer therapy are not recommended during pregnancy. We investigated the effects of...
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