BIOLOGICAL TESTING FACILITY (BTF) - NONCLINICAL FEMALE CONTRACEPTIVE DEVELOPMENT SERVICES

尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所的避孕研究处（CRB）支持研究开发能够破坏卵子发生、精子发生、正常排卵、精子成熟和/或功能的化合物，从而为男性和/或女性提供安全有效的避孕药具。生物检测设备（BTF）旨在允许快速评估新的物质组合物、药物制剂、输送系统和避孕活性装置。BTF提供全面的项目管理和能力，以支持根据开发新的避孕方法的所有阶段的非临床活动：这些包括但不限于体外和体内试验、血浆和微粒体稳定性研究、吸收、分布、代谢、排泄（ADME）、毒性、药代动力学（PK）和药效学（PD）分析、动物活动和研究、活性药物成分（api）的生产、工艺和产品开发、配方、临床批量生产、临床前使能研究和相关任务导致提交研究性新药（IND）或研究性器械豁免（IDE）申请。BTF有能力根据现行的良好生产规范（cGMP）制备化合物，以便进行临床评价。生物测试设施在CRB的产品开发任务中起着至关重要的作用。

The Contraception Research Branch (CRB) within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports research to develop compounds that can disrupt oogenesis, spermatogenesis, normal ovulation, sperm maturation and/or function affording safe and effective contraceptives that can be implemented for men and/or women. The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions-of- matter, drug formulations, delivery systems, and devices for contraceptive activity. The BTF provides overall project management and the capabilities to support all phases of nonclinical activities pursuant to development of new contraceptives methods: these include, but are not limited to in vitro and in vivo assays, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion (ADME), toxicity, Pharmacokinetic (PK) and Pharmacodynamic (PD) profiling, animal activities and studies, manufacture of active pharmaceutical ingredients (APIs), process and product development, formulation, clinical lot production, preclinical enabling studies and associated tasks leading to the filing of investigational new drug (IND) or Investigational Device Exemption (IDE) applications. The BTF has the capability to prepare compounds under current Good Manufacturing Practices (cGMP) to allow clinical evaluation. The Biological Testing Facility plays a critical role in the product development mission of the CRB.