AMINOTHIOL THERAPY IN NEPHROPATHIC CYSTINOSIS

氨基硫醇治疗肾病性胱氨酸贮积症

• 批准号: 6113426
• 负责人: JESS G THOENE
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113426
• 关键词: child (0-11); clinical research; cysteamine; cystinosis; drug metabolism; drug screening /evaluation; human subject; human therapy evaluation; kidney disorder chemotherapy; metabolism disorder chemotherapy; pediatric pharmacology; pharmacokinetics

Cysteamine therapy of nephropathic cystinosis received new drug approval from the FDA on August 15, 1994. The clinical investigation leading to new drug approval was initiated by Dr. Thoene at the University of Michigan in 1978. At this time the above referenced protocol is maintained to assist those children who cannot tolerate the marketed version which is prepared only in 50 mg and 200 mg capsules.

1994年8月15日，FDA获得了FDA的新药物批准。1978年，Thoene博士于1978年在密歇根大学的Thoene博士发起了新的药物批准的临床调查。此时，该协议可维持上述方案，以帮助那些仅在50 mg和200 m capsules中准备好的市场。