BIOLOGICAL TESTING FACILITY - "CONTRACEPTIVE DRUG AND INTRAVAGINAL CONTRACEPTIVE DEVICE EVALUATION"

生物测试设施 - “避孕药物和阴道内避孕器具评估”

基本信息

批准号：
10271538
负责人：
TOUFAN PARMAN
金额：
$ 70万
依托单位：
SRI INTERNATIONAL
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-22 至 2021-09-21
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10271538
关键词：
Animals Biological Assay Biological Testing Chemicals Clinical Contraceptive Agents Contraceptive Devices Contraceptive methods Data Development Device or Instrument Development Devices Drug Formulations Drug Kinetics Evaluation Excretory function Female Contraceptive Agents Formulation In Vitro Investigation Investigational Drugs Male Contraceptive Agents Metabolism Mission National Institute of Child Health and Human Development Oogenesis Ovulation Pharmaceutical Preparations Pharmacologic Substance Pharmacology Phase Plasma Play Process Research Research Personnel Research Support Role Safety Services Sperm Maturation Spermatogenesis System Testing Toxic effect United States Food and Drug Administration Woman absorption chemical synthesis clinical lot design in vivo lot production men novel novel therapeutics pharmacokinetics and pharmacodynamics pre-clinical product development research clinical testing

项目摘要

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 preclinical 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.

Eunice Kennedy Shriver国家研究所内的避孕研究部（CRB）儿童健康与人类发展（NICHD）支持研究可能破坏的化合物卵子发生，精子发生，正常排卵，精子成熟和/或功能提供可以针对男性和/或妇女实施的安全有效的避孕药。生物学测试设施（BTF）旨在快速评估新的成分，药物避孕活动的配方，输送系统和设备。 BTF提供总体项目管理和支持临床前所有阶段的能力根据开发新避孕方法方法的活动：其中包括但不限于体外和体内测定，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，生产活性药物成分（API），过程和产品开发，配方，临床生产，临床前促进研究和相关导致提交研究性新药（IND）或研究装置的任务豁免（IDE）申请。 BTF具有在电流下制备化合物的能力良好的制造实践（CGMP）允许临床评估。 BTF一直在与化学合成设施和CCTN的COR以及CCTN中的研究人员开发并测试适当的候选化合物临床批次的形成。这生物测试设施在CRB的产品开发任务中起着至关重要的作用。