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

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。这些研究的目的是在各种明确的毒理学和安全药理学研究中确定Cytisine的安全性，并建立最大耐受剂量（MTD）和未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 Part 58中描述的美国FDA“非临床实验室研究良好实验室规范”（GLP）进行。本研究的资料可用于确定拟议的人体剂量的适宜性。

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.