REQUEST FOR STORAGE AND STABILITY STUDY OF DRUG SUBSTANCES AND PRODUCTS

原料药和产品的储存和稳定性研究请求

• 批准号: 10912133
• 金额: $ 0.97万
• 依托单位: POLYPEPTIDE LABORATORIES SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-08 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10912133
• 关键词: Adolescent; Child Development; Clinical; Clinical Trials; Collaborations; Contraceptive Agents; Contractor; Contracts; Ethics; Failure; Government; Growth and Development function; Health; Infant; KISS1 gene; Laboratories; Longevity; Mentors; Mission; National Institute of Child Health and Human Development; Personal Satisfaction; Pharmaceutical Preparations; Population; Pregnant Women; Protocols documentation; Reproduction; Research; Shipping; Vendor; Vial device; Vision; Woman; Writing; cost; innovation; men; population health; stability testing

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Division of Population Health Research (DiPHR) aims to be a leader in population health research by focusing on successful reproduction, the health and well-being of pregnant women and their infants, and the optimal growth and development of children and adolescents across the lifespan. With the population as its observational laboratory, the division uses collaboration, discovery, ethics, innovation, interdisciplinary teamwork, and mentoring as core values in fulfilling its mission and vision. NICHD needs a contractor to hold Government owned vials of clinical grade Acyline, bulk clinical grade Acyline and Metastin and bulk research grade Acyline. They will be under stability testing protocol for these vials and bulk substance to support planned and ongoing clinical trials. There is an ongoing need for stability test of the clinical grade vialed and bulk Acyline and Metastin. This is to ensure that the drug substance or product is stable when it goes into clinical trial. These drug products must be stored at -20C, and contracting and shipping them to another vendor is not cost effective. Failure to maintain these drug products would delay ongoing clinical trials and add significant cost to the Government.

Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD）人口健康研究部（DiPHR）旨在成为人口健康研究的领导者，重点关注成功生殖，孕妇及其婴儿的健康和福祉，以及儿童和青少年在整个生命周期的最佳生长和发育。人口作为其观察实验室，该部门使用协作，发现，道德，创新，跨学科团队合作和指导作为实现其使命和愿景的核心价值观。 NICHD需要一个承包商来持有政府拥有的临床级Acyline、散装临床级Acyline和Metastin以及散装研究级Acyline小瓶。将根据这些小瓶和散装物质的稳定性检测方案进行检测，以支持计划和正在进行的临床试验。目前仍需要对临床级瓶装和散装Acyline和Metastin进行稳定性试验。这是为了确保原料药或产品在进入临床试验时保持稳定。这些药物产品必须储存在-20 ℃下，将其承包并运送给另一家供应商是不划算的。如果不能维持这些药物产品，将延误正在进行的临床试验，并给政府增加大量费用。