Comprehensive Resources for HIV Microbicides and Biomedical Prevention: Quality Assurance/ Quality Control (QA/QC)

HIV 杀菌剂和生物医学预防的综合资源：质量保证/质量控制 (QA/QC)

• 批准号: 10926784
• 负责人: RANAJIT PAL
• 金额: $ 2万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2019-07-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10926784
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Clinical Trials; Contracts; Development; HIV Infections; Licensure; National Institute of Allergy and Infectious Disease; Persons; Play; Prevention; Prevention strategy; Preventive vaccine; Quality Control; Recurrence; Resources; Role; Technology; United States National Institutes of Health; Work; anti-HIV microbicide; microbicide; pre-clinical; pre-exposure prophylaxis; 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.

HIV 杀菌剂和生物医学预防的综合资源：制定高效的 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，仍然是艾滋病司 (DAIDS) 和艾滋病毒部门的最高优先事项之一。美国国立卫生研究院 (NIH) 下属的国家过敏和传染病研究所 (NIAID) 目前估计全球艾滋病毒感染人数超过 3300 万人，因此开发安全、有效且可接受的 nBP 产品是为了随着有前途的 nBP 产品（例如杀微生物剂、暴露前预防 (PrEP) 剂和多用途预防技术 (MPT)）的出现，预防艾滋病毒的性传播可以在全球范围内每天减少约 5000 例新艾滋病毒感染中发挥重要作用。 ），迫切需要快速有效地将这些候选药物转移到临床测试中，工作范围包括从最初的产品发现到支持临床试验和/或产品所需的临床前活动。执照。