Article ID Journal Published Year Pages File Type
5857134 Regulatory Toxicology and Pharmacology 2012 8 Pages PDF
Abstract
► Sitaxentan toxicity was assessed in juvenile rats. ► Using multiple endpoints, there were no safety concerns specific to juvenile rats. ► Changes identified related to expected pharmacology. ► Regulatory interactions supported study design and justification.
Keywords
Related Topics
Life Sciences Environmental Science Health, Toxicology and Mutagenesis
Preview
Evaluation of sitaxentan (Thelin®) toxicity in juvenile rats and regulatory interactions during the development of a European Medicines Agency pediatric investigation plan
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