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.

临床前和临床开发和监管评估核心（Core B）将负责