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

将要求生物测定开发顾问评价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/或鉴定/验证测定，用于临床和非临床研究。 可能要求生物测定顾问协助建立与测定优化或验证相关的里程碑。 生物测定可用于测量生产研究中的制剂和/或从临床和/或非临床研究中获得的血清或组织样品。NIH可能会就常用体外试验（如生化和/或基于细胞的试验）的设计和解释向顾问寻求指导。具体的咨询责任将取决于个别顾问的专业知识和个别项目的需求。可能需要临时或在LDT上提供与生物测定有关的咨询服务。

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.