Expertise in Development of Pediatric Drug Formulations

儿科药物制剂开发的专业知识

• 批准号: 10927009
• 负责人: PETER SILVERA
• 金额: $ 40.87万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2030-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10927009
• 关键词: AIDS prevention; Adolescent; Age; Child; Childhood; Collaborations; Communities; Contraceptive Agents; Contracts; Development; Devices; Drug Formulations; Extramural Activities; Formulation; HIV; Infant; Investigator-Initiated Research; Knowledge; Modeling; National Institute of Allergy and Infectious Disease; Pediatrics; Prevention; Private Sector; Regulatory Pathway; Research; Resources; Science; Services; antiretroviral therapy; co-infection; experience; novel therapeutics; pediatric drug development; pharmacometrics; pre-clinical; product development; research clinical testing; research study; therapeutic development

The objective of the Resource to Advance Pediatrics and HIV Prevention Science contracts is to provide the extramural scientific community with research materials and preclinical product development support for candidate products that emerge from investigator-initiated research studies, or from collaborations with private sector or academic partners. These services may also be used to support product discovery and development leading to IND, Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the FDA. NIAID will primarily use these contracts to fill critical development and resource gaps more rapidly and efficiently and advance promising products into clinical testing. The focus of these contracts will be development of therapeutics and prevention products for HIV, including single or combination products with activity against associated co-infections or MPTs that incorporate contraceptives.

推进儿科和艾滋病毒预防科学资源合同的目标是为校外科学界提供研究材料和临床前产品开发支持，以支持研究者发起的研究或与私营部门或学术伙伴合作产生的候选产品。这些服务还可用于支持产品发现和开发，从而向 FDA 提交 IND、研究器械豁免 (IDE) 和/或新药申请 (NDA)。 NIAID 将主要利用这些合同来更快速、更有效地填补关键的开发和资源缺口，并将有前景的产品推进临床测试。这些合同的重点将是开发艾滋病毒治疗和预防产品，包括具有抗相关合并感染活性的单一或组合产品或包含避孕药具的 MPT。