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

生物测试设施 (BTF) - 非临床女性避孕开发服务

基本信息

批准号：
10710081
负责人：
DEBRA BURNIN
金额：
$ 110万
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：
2020-08-30 至 2025-08-29
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10710081
关键词：
Acute Animals Binding Proteins Biological Assay Biological Availability Biological Testing Canis familiaris Cervical Chemicals Chronic Clinical Clinical Trials Contraceptive Agents Contraceptive Devices Contraceptive methods Contractor Country Data Development Devices Documentation Drug Exposure Drug Formulations Drug Kinetics Drug Stability Evaluation Excretory function Female Contraceptive Agents Fertility Formulation Generations Genetic In Vitro Intramuscular Investigation Investigational Drugs Male Contraceptive Agents Measures Medical Device Metabolic Metabolism Mission Mus National Institute of Child Health and Human Development Oogenesis Oral Oryctolagus cuniculus Ovary Ovulation Performance Pharmaceutical Preparations Pharmacologic Substance Pharmacology Phase Plasma Plasma Proteins Play Preparation Process Progress Reports Rattus Regulation Reporting Research Research Support Role Route Safety Services Sheep Sperm Maturation Sperm Motility Spermatogenesis System Teleconferences TimeLine Tissues Toxic effect Toxicokinetics United States Food and Drug Administration Uterus Vagina Validation Woman absorption analytical method authority clinical lot cytotoxicity design egg good laboratory practice in vivo in vivo Model lot production men nonhuman primate novel novel therapeutics pharmacokinetics and pharmacodynamics pre-clinical product development reproductive organ research clinical testing sperm cell subcutaneous

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 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）支持研究，以破坏卵子发生，精子发生，正常排卵，精子成熟和/或功能，可提供安全有效的避孕避孕避孕药具可以针对男性和/或女性实施。生物测试设施（BTF）旨在允许对新的物质，药物配方，输送系统和避孕活动设备进行快速评估。 BTF提供了总体项目管理和支持非临床活动的所有阶段的能力，根据开发新的避孕方法：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，分布，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）的制造（API），过程和产品开发，配方，临床批次，临床批次生产，临床上的研究以及相关的任务以及相关的任务导致提交研究新药（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。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。