DEVELOP A QUALITY ASSURANCE/QUALITY CONTROL (QA/QC) PLAN FOR ACTIVITIES CONDUCTED UNDER TASK AREA D.

为任务领域 D 下开展的活动制定质量保证/质量控制 (QA/QC) 计划。

• 批准号: 9545135
• 负责人: GITA SHANKAR
• 金额: $ 2.73万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9545135
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Area; Clinical Research; Clinical Trials; Development; HIV; HIV Infections; Licensure; National Institute of Allergy and Infectious Disease; Play; Prevention; Prevention strategy; Preventive vaccine; Quality Control; Resources; Role; Technology; United States Food and Drug Administration; United States National Institutes of Health; Work; microbicide; pre-clinical; pre-exposure prophylaxis; preclinical study; prevent; quality assurance; research clinical testing; sexual HIV transmission

Comprehensive Resources for HIV Microbicides and Biomedical Prevention: The development of highly effective HIV prevention strategies, including a preventive vaccine and other non-vaccine biomedical prevention (nBP) products, remains one of the highest priorities for the Division of AIDS (DAIDS) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). With current global HIV infection estimates exceeding 33 million people, the development of safe, effective, and acceptable nBP products to prevent the sexual transmission of HIV could play a major role in the worldwide reduction of the estimated 5000 new HIV infections per day. As promising nBP products emerge (e.g., microbicides, pre-exposure prophylaxis (PrEP) agents, and Multipurpose Prevention Technologies (MPT’s), there is a critical need to rapidly and efficiently move these candidates into clinical testing. The scope of work encompasses preclinical activities that range from initial product discovery to those required to support clinical trials and/or product licensure. Activities under this area will provide support for HIV nBP product manufacturing and product characterization to preclinical and clinical studies as well as other activities required by the U.S. Food and Drug Administration (FDA) to advance these HIV nBP products into clinical testing. Quality control and quality assurance plans will be developed to support product manufacturing.

HIV杀微生物剂和生物医学预防的综合资源：开发高效的HIV预防策略，包括预防性疫苗和其他非疫苗生物医学预防（nBP）产品，仍然是美国国立卫生研究院（NIH）艾滋病司（DAIDS）和国家过敏和传染病研究所（NIAID）的最高优先事项之一。目前全球HIV感染估计超过3300万人，开发安全、有效和可接受的nBP产品来预防HIV的性传播，可以在全球范围内减少每天约5000例新的HIV感染方面发挥重要作用。随着有前途的nBP产品的出现（例如，除了杀微生物剂、暴露前预防（PrEP）剂和多用途预防技术（MPT）之外，迫切需要快速有效地将这些候选物投入临床测试。工作范围包括临床前活动，从最初的产品发现到支持临床试验和/或产品许可所需的活动。 该领域的活动将为HIV nBP产品生产和产品表征提供支持，以进行临床前和临床研究，以及美国食品药品监督管理局（FDA）要求的其他活动，以将这些HIV nBP产品推进临床测试。 将制定质量控制和质量保证计划，以支持产品制造。