Advanced Preclinical and Clinical Development and Regulatory Evaluations

先进的临床前和临床开发以及监管评估

• 批准号: 8132428
• 负责人: Robert Walter Buckheit
• 金额: $ 87.07万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8132428
• 关键词: Acyclovir; Animal Model; Anti-Infective Agents; Biological; Clinical; Clinical Trials; Contracts; Data; Detection; Development; Dose; Drug Kinetics; Evaluation; Human; Intention; Investigation; Lead; Materials Testing; Methods; Modeling; Mus; Oryctolagus cuniculus; Performance; Pharmaceutical Preparations; Pharmacodynamics; Pharmacologic Substance; Pharmacology and Toxicology; Phase; Preclinical Testing; Preparation; Prevention; Qualifying; Quality Control; Rattus; Safety; Science; Services; Shipping; Ships; Solutions; Tenofovir disoproxil fumarate; Testing; Toxic effect; Toxicology; Vaginal Ring; absorption; base; experience; irritation; member; microbial alkaline proteinase inhibitor; microbicide; nonhuman primate; particle; phase 1 study; pre-clinical; product development; programs; repository; research clinical testing; safety study; safety testing; transmission process

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.

临床前和临床开发及监管评估核心（核心 B）将负责 提供测试材料供该计划的所有组成部分使用，包括执行的分包商 动物模型和毒理学研究，以及监管的整体项目管理 最终环产品的开发。因此，ImQuest BioSciences 工作人员将协调合成， 评估所需化合物的储存和运输、与监管顾问的互动 负责对环产品的开发、安全性能提供建议 药理学和毒理学测试，包括刺激和吸收研究、GMP的合成 用于环产品中使用的材料以及用于提交预 IND 和导致预试验的 IND 文件的材料 第一阶段人体临床试验。