This service is for The BPN Biologics program requires bioassay development expertise in order to support active cooperative agreements for drug development and discovery.

该服务适用于 BPN Biologics 计划需要生物测定开发专业知识，以支持药物开发和发现的积极合作协议。

• 批准号: 10949343
• 金额: $ 1万
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-30 至 2024-07-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10949343
• 关键词: service; BPN; Biologics; program; requires

Bioassay development consultants will be required to evaluate or develop bioassay development plans and recommend strategies and experiments to optimize assays and/or qualify/validate the assays, for use in a clinical and nonclinical studies. Bioassay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. Bioassays may be used to measure drug product in manufacturing studies, and/or in serum or tissue samples obtained from clinical and/or nonclinical studies. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and/or cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. Bioassay-related consultation services may be required on an ad hoc basis or on LDTs.

生物测定开发顾问将被要求评估或制定生物测定开发计划，并推荐策略和实验，以优化测定和/或合格/验证测定法，以用于临床和非临床研究。 可以要求生物测定顾问协助建立与测定优化或验证有关的里程碑。 生物测定可用于测量制造研究中的药物，以及/或从临床和/或非临床研究获得的血清或组织样品中。 NIH可能会向顾问寻求有关通常体外测定法的设计和解释，例如生化和/或基于细胞的测定法。具体的咨询职责将取决于个人顾问的专业知识和各个项目的需求。可能需要临时或在LDTS上进行生物测定相关的咨询服务。