NONCLINICAL CONTRACEPTIVE VAGINAL GEL DEVELOPMENT SERVICES

非临床避孕阴道凝胶开发服务

基本信息

批准号：
10497248
负责人：
DEBORAH BURNIN
金额：
$ 77.5万
依托单位：
SRI INTERNATIONAL
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-21 至 2023-09-21
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10497248
关键词：
Animals Biological Assay Biological Testing Chemicals Clinical Contraceptive Agents Contraceptive Devices Contraceptive methods Contractor Country Data Development Devices Documentation Drug Formulations Drug Kinetics Evaluation Excretory function Female Contraceptive Agents Formulation In Vitro Investigation Investigational Drugs Metabolism Mission National Institute of Child Health and Human Development Oogenesis Ovulation 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 Vaginal Gel Woman absorption authority 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 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.

Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD）内的避孕研究部（CRB）支持开发可以破坏卵子发生，精子发生，正常排卵，精子成熟，精子成熟和/或功能的化合物，从而为男性和女性提供可实施的安全和有效避孕药。生物测试设施（BTF）旨在允许对避孕活动的物质，药物配方，输送系统和设备进行快速评估。 BTF提供了总体项目管理和支持新避孕药方法的非临床活动的所有阶段的能力：这些方法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，吸收，吸收，分布，分布，代谢，毒性（ADME），药物（PK）（PK）（PK）（PK）（PK）（PK）（PK）（PK）（PK）研究，生产活性药物成分（API），过程和产品开发，配方，临床批次生产，临床前促成研究以及相关任务，导致提出研究新药（IND）或研究设备豁免（IDE）应用。 BTF具有在当前良好的制造实践（CGMP）下制备化合物的能力，以允许临床评估。 BTF一直与CORS合成化学合成设施和CCTN以及CCTN中的研究人员，以开发和测试适当的候选化合物临床批次的形成。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。