BIOLOGICAL TESTING FACILITY (BTF) - DEVELOPMENT OF CONTRACEPTIVE PRODUCTS INTENDED FOR NON-SYSTEMIC DELIVERY

生物测试设施 (BTF) - 开发用于非系统分娩的避孕产品

基本信息

批准号：
10936055
负责人：
DEBORAH BUNIN
金额：
$ 137.23万
依托单位：
SRI INTERNATIONAL
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-21 至 2025-09-20
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10936055
关键词：
Acute Animals Authorization documentation Binding Proteins Biological Assay Biological Availability Biological Products 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 Good Manufacturing Process Implant In Vitro Injectable Intramuscular Intravenous Investigational Drugs Male Contraceptive Agents Measures Medical Device Metabolism Microsomes Mission Mus National Institute of Child Health and Human Development Oogenesis Oral Oryctolagus cuniculus Ovary Ovulation Pharmaceutical Preparations Pharmacologic Substance Pharmacology Phase Placebos Plasma Plasma Proteins Play Preparation Prevention Process Progress Reports Property Protocols documentation Rattus Regulation Reporting Research Research Support Role Route Safety Services Sheep Sperm Maturation Spermatogenesis System Teleconferences Testing Tissues Toxic effect Toxicokinetics Toxicology United States Food and Drug Administration Uterus Vagina Woman absorption analytical method authority clinical lot cytotoxicity data sharing design drug testing egg good laboratory practice in vivo in vivo Model lot production manufacture men nonhuman primate novel novel therapeutics penis pharmacokinetics and pharmacodynamics pre-clinical product development reproductive reproductive organ research clinical testing sperm cell sperm function subcutaneous timeline vaginal microbiome

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, use cases for existing chemical matter, drug formulations, delivery systems, and devices for contraceptive and/or contraceptive-containing multipurpose prevention (cMPT) 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 capabilities include but are not limited to assays (in vitro, ex vivo and in vivo); 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 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 and conduct studies under current good laboratory practices (cGLP). The BTF 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）旨在允许对物质的新组成，现有化学物质，药物配方，输送系统和避孕和/或含避孕药的预防（CMPT）活性的新成分进行快速评估。 BTF提供了总体项目管理和根据开发新避孕方法的方法来支持非临床活动的所有阶段的能力。这些功能包括但不限于测定（体外，体内和体内）；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；活性药物成分（API）的生产；过程和产品开发；配方；临床生产；临床前促进研究；以及导致调查新药物（IND）或研究设备豁免（IDE）应用的相关任务。 BTF具有在当前良好的制造实践（CGMP）下制备化合物的能力，以允许在当前良好的实验室实践（CGLP）下进行临床评估和进行研究。 BTF在CRB的产品开发任务中起着至关重要的作用。