BIOLOGICAL TESTING FACILITY (BTF): TASK ORDER 12- "FORMULATION AND PHARMACEUTICAL CHARACTERIZATION OF MULTIPURPOSE PREVENTION CONTRACEPTION PREVENTION

尤尼斯·肯尼迪·施莱弗国家研究院内的避孕研究分会 儿童健康和人类发展(NICHD)支持研究开发能够 干扰卵子发生、精子发生、正常排卵、精子成熟和/或功能，为男性和/或女性提供安全有效的避孕措施。生物检测机构(BTF)的设计目的是允许快速评估新的成分--物质、药物配方、给药系统和避孕活动装置。BTF根据新避孕药方法的开发提供全面的项目管理和能力，以支持非临床活动的所有阶段：这些方法包括但不限于体外和体内分析、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)概况、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、临床前使能研究和导致研究新药(IND)或研究设备豁免(IDE)申请的相关任务。BTF有能力根据当前的良好制造规范(CGMP)制备化合物，以便进行临床评估。BTF一直在与化学合成设施和CCTN的CORS以及CCTN的调查人员合作，为候选化合物的临床批次开发和测试适当的构型。生物检测机构在CRB的产品开发任务中发挥着关键作用。

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-ofmatter, 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 BTF has been working with the CORs for the Chemical Synthesis Facility and the CCTN and with investigators in the CCTN to develop and test the appropriate formation for clinical batches of the candidate compounds. The Biological Testing Facility plays a critical role in the product development mission of the CRB.