BIOLOGICAL TESTING FACILITY – IN VITRO METABOLIC AND IN VIVO PRECLINICAL STUDIES

生物测试设施 – 体外代谢和体内临床前研究

基本信息

批准号：
10705350
负责人：
DEBRA BURNIN
金额：
$ 60.49万
依托单位：
SRI INTERNATIONAL
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-12 至 2024-09-11
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10705350
关键词：
Androgens Animal Model Animals Area Biological Testing Blood Chemicals Clinical Clinical Research Clinical Trials Clinical Trials Network Contraceptive Agents Contraceptive Devices Contraceptive Usage Contraceptive methods Contractor Development Documentation Drug Evaluation Drug Formulations Drug Kinetics Endocrine Enrollment Evaluation Excretory function Formulation Goals Hormones In Vitro Injectable Investigational New Drug Application Metabolic Metabolism Methods Mission National Institute of Child Health and Human Development Oral Ovulation Pharmaceutical Preparations Pharmacodynamics Pharmacologic Substance Phase Plasma Play Process Prodrugs Production Progestins Program Development Proteins Protocols documentation Reporting Research Research Personnel Research Support Role Route Safety System Testing Time Tissues Toxic effect Toxicology Woman absorption androgenic chemical synthesis clinical lot design drug candidate drug development efficacy evaluation estrogenic in vitro Assay in vivo lot production men novel therapeutics pharmacokinetics and pharmacodynamics population health pre-clinical pre-clinical research preclinical study product development programs recruit research and development research clinical testing sperm cell sperm function stability testing

项目摘要

Within Division of Intramural Population Health Research at NICHD, the Contraceptive Development Program (CDP) supports research to develop potential contraceptive compounds that can disrupt normal ovulation, sperm production or sperm function for the purpose of developing safe, effective, and affordable contraceptives for women or men. The Biological Testing Facility (BTF) is designed to allow rapid evaluation of new chemical entities (NCE), drug formulations, delivery systems, and devices for contraceptive and endocrine activity. The BTF provides overall project management and the capabilities to support all phases of preclinical activities pursuant to development of new contraceptive methods: these include, but are not limited to in vitro assays and in vivo studies, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion and toxicity (ADMET), 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) applications. Compounds formulated by the BTF are prepared under current Good Manufacturing Practices (cGMP) to allow clinical evaluation in the CDP Contraceptive Clinical Trials Network (CCTN). The CCTN investigators have develop protocols to evaluate the drug candidates identified as high priority by the Program. The BTF has been working with the CORs for the Chemical Synthesis Facility and the CCTN and with the investigators in the CCTN to develop and test the appropriate formulations for clinical batches of the candidate compounds. The next clinical study for each candidate drug is dependent on timely receipt of clinical batches to begin the process of recruitment and enrollment. Drugs that are currently in ongoing clinical trials require stability testing of the clinical formulations. The Biological Testing Facility plays a critical role in the drug development mission of the CDP.

在NICHD的壁内人群健康研究中，避孕开发计划（CDP）支持研究，以开发潜在的避孕化合物，这些化合物可能破坏正常的排卵，精子产生或精子功能，目的是为了开发安全，有效且负担得起的女性或男性。生物测试设施（BTF）旨在快速评估新的化学实体（NCE），药物制剂，输送系统和避孕和内分泌活性的设备。 The BTF provides overall project management and the capabilities to support all phases of preclinical activities pursuant to development of new contraceptive methods: these include, but are not limited to in vitro assays and in vivo studies, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion and toxicity (ADMET), pharmacokinetic (PK) and pharmacodynamic (PD) profiling, animal activities and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，临床前启用研究以及相关任务，导致提出研究新药（IND）应用。由BTF制定的化合物是根据当前良好的制造实践（CGMP）制备的，以允许在CDP避孕临床试验网络（CCTN）中进行临床评估。 CCTN研究人员已经制定了协议，以评估该计划被确定为高优先级的候选药物。 BTF一直与CORS合成化学合成设施和CCTN以及CCTN中的研究人员开发和测试适当的候选化合物临床批次配方。每种候选药物的下一项临床研究取决于及时接收临床批次，以开始招募和入学过程。目前正在进行的临床试验的药物需要对临床配方进行稳定性测试。生物测试设施在CDP的药物开发任务中起着至关重要的作用。