TOXICOLOGY OF IRON ORAL CHELATING COMPOUNDS

本项目的目的是进行毒理学评价， 动物口服铁螯合化合物，用于安全和 有效清除铁过载患者体内的铁沉积 条件（例如，库利氏贫血，一种孤儿病）。 临床 此时不需要评估。 承包商应进行 铁螯合化合物的毒理学和相关研究， 老鼠、狗和项目官员指示的其他动物，以及 应向NIDDK提供由此产生的毒理学信息， 准备提交给食品和药物管理局批准 最终的临床研究。 正在开发的药物被认为是 成为孤儿药

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.