TOXICOLOGY OF IRON ORAL CHELATING COMPOUNDS

该项目的目的是获得毒理学评估，在 动物，口服铁络合物制，用于安全和 铁负荷过高患者铁沉积的有效清除 病症(例如，库利氏贫血，一种孤儿疾病)。一家诊所 目前不希望进行评估。承包商应进行 部分铁络合物的毒理学和相关研究，在 由项目官员指示的老鼠、狗和其他动物，以及 应将产生的毒理学信息提供给NIDDK用于 准备提交给食品和药物管理局审批的文件 最终的临床研究。正在开发的药物被认为是 成为孤儿毒品。

The purpose of this project is to procure the toxicologic evaluation, in animals, of oral iron chelating compounds, for use in the safe and effective removal of iron deposits in patients with iron overload conditions (e.g., Cooley's anemia, an orphan disease). A clinical evaluation is not desired at this time. The contractor shall conduct toxicologic and related studies of selected iron chelating compounds, in rats, dogs, and other animals as directed by the Project Officer, and shall provide resulting toxicologic information to the NIDDK for use in preparing submissions to the Food and Drug Administration for approval of eventual clinical studies. The drugs under development are considered to be orphan drugs.