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中文摘要
翻译
承包商应独立提供所有必要的服务、合格的人员、材料、设备和设施,以维持和运营生物检测设施(BTF),以支持国家儿童健康和人类发展研究所(CRHB)的避孕和生殖健康分部,而不是作为政府代理人。本合同支持的BTF应提供设施和人员,在体内、体外和体外执行广泛的筛选、分析、安全测试和分析程序,以评估与政府提供的化合物的内分泌和抗生育活性有关的新药、制剂和给药系统,并管理所获得的数据。 生物检测设备-十一酸二甲雄酮(DMAU)避孕药及其进一步的制造、配方、稳定性和检测。 生物检测设施旨在允许快速评估新的物质成分、药物配方、给药系统和用于抗生育或避孕和内分泌活动的装置。
英文摘要
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.
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PK/PD, METABOLIC, AND PRECLINICAL STUDIES - SRI INTERNATIONAL
  • 批准号:
    10833878
  • 项目类别:
  • 资助金额:
    $208.5万
  • 财政年份:
    2023
  • 负责人:
    DEBRA BURNIN
  • 依托单位:
BIOLOGICAL TESTING FACILITY (BTF): TASK ORDER 12- "FORMULATION AND PHARMACEUTICAL CHARACTERIZATION OF MULTIPURPOSE PREVENTION CONTRACEPTION PREVENTION
  • 批准号:
    10706872
  • 项目类别:
  • 资助金额:
    $5.35万
  • 财政年份:
    2022
  • 负责人:
    DEBRA BURNIN
  • 依托单位:
BIOLOGICAL TESTING FACILITY (BTF) - NONCLINICAL MALE CONTRACEPTIVE DEVELOPMENT SERVICES
  • 批准号:
    10705348
  • 项目类别:
  • 资助金额:
    $35.26万
  • 财政年份:
    2022
  • 负责人:
    DEBRA BURNIN
  • 依托单位:
BIOLOGICAL TESTING FACILITY – IN VITRO METABOLIC AND IN VIVO PRECLINICAL STUDIES
  • 批准号:
    10705350
  • 项目类别:
  • 资助金额:
    $60.49万
  • 财政年份:
    2022
  • 负责人:
    DEBRA BURNIN
  • 依托单位:
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