NIAID Preclinical Development Support

NIAID 临床前开发支持

• 批准号: 9298495
• 负责人: PHILLIP ISHIKAWA
• 金额: $ 239.03万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-29 至 2017-08-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9298495
• 关键词: AIDS prevention; Contracts; Data; Development; Documentation; HIV vaccine; Investigational Drugs; Investigator-Initiated Research; Modality; National Institute of Allergy and Infectious Disease; Pamphlets; Phase; Preclinical Testing; Process; Production; Protocols documentation; Research Personnel; Safety; Testing; authority; flexibility; immunogenicity; microbicide; pre-clinical; research clinical testing; research study

This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing.

这份合同将为NIAID提供广泛和灵活的非传统、前瞻性和面向开发的能力，当有前景的产品从研究人员发起的研究中出现时，为这些产品提供临床前开发支持。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。活动包括但不限于小规模生产、临床前测试和导致研究新药(IND)提交第一、第二和第三阶段临床测试的文件。