BIOLOGICAL TESTING FACILITY - DMAU

生物测试设施 - DMAU

• 批准号: 10787964
• 负责人: DEBRA BURNIN
• 金额: $ 0.36万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-29 至 2015-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10787964
• 关键词: Animals; Biological; Biological Assay; Biological Testing; Castor Oil; Clinical; Clinical Trials; Contraceptive Agents; Contraceptive methods; Contractor; Development; Devices; Dosage Forms; Dose; Drug Formulations; Endocrine; Equipment; Evaluation; Fertility; Formulation; Funding; Good Manufacturing Process; Government; Government Agencies; Human; Human Resources; In Vitro; Investigation; National Institute of Child Health and Human Development; Pharmaceutical Preparations; Placebos; Powder dose form; Preparation; Procedures; Qualifying; Quality Control; Regulation; Reproductive Health; Route; Services; Shipping; Support Contracts; System; Testing; Validation; Work; analytical method; data management; design; human subject; improved; in vivo; manufacture; novel therapeutics; safety testing; stability testing; uptake

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment and facilities not otherwise provided by the Government as needed to maintain and operate a Biological Testing Facility (BTF) in support of the Contraception and Reproductive Health Branch (CRHB) of the National Institute of Child Health and Human Development. The BTF supported by this contract shall provide the facilities and personnel to perform a wide range of screens, assays, safety tests and analytical procedures, in vivo, in vitro, and ex vivo, for the evaluation of new drugs, formulations and delivery systems relevant to endocrine and anti-fertility activity of compounds that are provided by the Government, and management of the data obtained. Biological Testing Facility - Dimethandrolone Undecanoate (DMAU) contraceptive and further Manufacture, Formulation, Stability and Testing. Biological Testing Facility is designed to permit rapid evaluation of new compositions of matter, drug formulations, delivery systems, and devices for anti-fertility or contraceptive and endocrine activity.

承包商应独立且不作为政府代理人，提供所有必要的服务、合格人员、材料、设备和设施（政府未提供），以维护和运营生物试验机构（BTF），支持国家儿童健康和人类发展研究所避孕和生殖健康分支（CRHB）。本合同支持的BTF应提供设施和人员，以进行体内、体外和离体的广泛筛选、测定、安全性试验和分析程序，以评价与政府提供的化合物的内分泌和抗生育活性相关的新药、制剂和输送系统，并管理所获得的数据。 生物试验机构-二甲雄龙十一酸酯（DMAU）避孕药和进一步生产、配制、稳定性和试验。 生物试验设施旨在快速评价新的物质组合物、药物配方、给药系统和抗生育或避孕和内分泌活性装置。