Characterization of Drug Substances in a Dual Indication Vaginal Ring for Prevention of HIV and Pregnancy

用于预防艾滋病毒和怀孕的双适应症阴道环中药物成分的表征

• 批准号: 10697056
• 负责人: PETER SILVERA
• 金额: $ 45.51万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10697056
• 关键词: AIDS prevention; Animal Model; Area; Characteristics; Collaborations; Contractor; Contracts; Dapivirine; Dosage Forms; HIV; Investigator-Initiated Research; Levonorgestrel; Morphology; National Institute of Allergy and Infectious Disease; Pharmaceutical Preparations; Pregnancy; Prevention; Resources; Services; Technology; Vaginal Ring; microbicide; particle; pre-clinical; product development; research study

The purpose of the Comprehensive Resources for Microbicides and Biomedical Prevention contract is to provide the NIAID with a comprehensive suite of preclinical product development services for candidate products that emerge from investigator-initiated research studies or from collaborations with outside companies or organizations. The Contractor shall provide: 1) Preclinical gap-filling services; 2) HIV animal models supporting product development; 3) Bioanalytical support services; 4) Product manufacturing; and 5) Scientific and quality/regulatory support services.

杀微生物剂和生物医学预防综合资源合同的目的是为NIAID提供一套全面的临床前产品开发服务，用于从制药商发起的研究或与外部公司或组织合作中产生的候选产品。承包商应提供：1）临床前填补空白服务; 2）支持产品开发的HIV动物模型; 3）生物分析支持服务; 4）产品制造;以及5）科学和质量/监管支持服务。