Advanced Preclinical and Clinical Development and Regulatory Evaluations

临床前和临床开发和监管评价核心（核心B）将负责 提供测试材料，供计划的所有组成部分使用，包括分包商 动物建模和毒理学研究，以及监管的整体项目管理 开发最终的戒指产品。因此，ImQuest BioSciences的工作人员将协调合成， 评价所需化合物的储存和运输，与监管顾问的互动 负责对吊环产品的开发、性能安全提供咨询 药理学和毒理学试验，包括刺激和吸收研究，GMP的合成 用于瓣膜成型环产品的材料以及用于提交IND前和IND前文件的材料。 1期人体临床试验。

The Preclinical and Clinical Developmental and Regulatory Evaluations Core (Core B) will be responsible for the provision of test materials for use by all components of the Program, including subcontractors performing animal modeling and toxicology studies, as well as overall Project Management of the regulatory development of the final ring products. Thus, ImQuest BioSciences staff will coordinate the synthesis, storage and shipping of compounds required for evaluation, the interactions with a regulatory consultant responsible for providing advice on the development of the ring product, the performance of safety pharmacology and toxicology testing, including irritation and absorption studies, the synthesis of GMP material for use in the ring product and for submission of the pre-IND and IND documents leading to the pre- Phase 1 human clinical trial.