IGF::OT::IGF IND DIRECTED SAFETY AND TOXICOLOGY STUDIES FOR CYTISINE

IGF::OT::IGF 针对金雀花碱的 IND 安全性和毒理学研究

• 批准号: 9153147
• 负责人: HANNA NG
• 金额: $ 75.16万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-03 至 2017-09-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9153147
• 关键词: Biological Assay; Canis familiaris; Cardiovascular system; Chromosome abnormality; Data; Dose; Human; In Vitro; Investigational Drugs; Investigational New Drug Application; Laboratory Study; Lung; Lymphocyte; Maximum Tolerated Dose; No-Observed-Adverse-Effect Level; Pharmacology; Rattus; Safety; Toxic effect; Toxicology; United States Food and Drug Administration; United States National Institutes of Health; cytisine; good laboratory practice; in vivo; micronucleus

The purpose of these studies is to provide data of suitable quality and integrity to support applications to the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The objective of the studies is to determine the safety profile and to establish a maximum tolerated dose (MTD) and no observed adverse effect level (NOAEL) of Cytisine in various definitive toxicology and safety pharmacology studies to support an Investigational New Drug (IND) application for this compound. The GLP studies will be performed in accordance with the U.S. FDA “Good Laboratory Practice for Nonclinical Laboratory Studies” (GLP) as described in 21 CFR Part 58. Information from this study may be used to determine the suitability of the proposed human dose.

这些研究的目的是提供适当质量和完整性的数据，以支持向美国食品和药物管理局 (FDA) 和其他监管机构的申请。这些研究的目的是确定金雀花碱的安全性，并在各种明确的毒理学和安全药理学研究中确定金雀花碱的最大耐受剂量（MTD）和无观察到的不良反应水平（NOAEL），以支持该化合物的研究性新药（IND）申请。 GLP 研究将按照 21 CFR 第 58 部分所述的美国 FDA“非临床实验室研究良好实验室规范”(GLP) 进行。本研究的信息可用于确定拟议人体剂量的适用性。