Comprehensive Toxicological Assessments for the National Toxicology Program

国家毒理学计划的综合毒理学评估

• 批准号: 8051077
• 金额: $ 1376.44万
• 依托单位: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8051077
• 关键词: Acquired Immunodeficiency Syndrome; Acrylamides; Address; Adverse effects; Agreement; Aloe vera plant; Alternative Medicine; Anesthetics; Brain; Caffeine; Cardiovascular Diseases; Cell Death; Chemicals; Childhood; Chondroitin; Chronic; Citrus aurantium; Communities; Complementary and alternative medicine; Cream; Data; Development; Diethylhexyl Phthalate; Disease; Drug Kinetics; Endocrine; Environmental Exposure; Evaluation; Exposure to; Furans; GABA Agonists; Generations; Glucosamine; Goals; Hazard Assessment; Health; Human; Immune system; Ketamine; Lamivudine; Legal; Lichen - organism; Light; Malignant Neoplasms; Medicine; Metabolism; Mus; N-Methylaspartate; Nanotechnology; National Institute of Environmental Health Sciences; National Toxicology Program; Nelfinavir; Neurosecretory Systems; Nevirapine; Oral; Oranges; Phototoxicity; Physiological; Pigments; Poison; Rattus; Research; Safety; Science; Services; Simulate; Skin; Sunlight; Testing; Therapeutic; Topical application; Toxic effect; Toxicokinetics; Toxicology; Ultraviolet Rays; United States Food and Drug Administration; United States National Institutes of Health; Usnea; Zidovudine; Zucker Rats; authority; base; carcinogenicity; developmental neurotoxicity; diabetic rat; dietary supplements; disorder prevention; efavirenz; nanoscale; nervous system disorder; nonylphenol; phthalates; programs; reproductive; retinyl palmitate; usnic acid

The primary goal of this project is to provide support of National Toxicology Program (NTP) hazard assessment activities targeted toward the prevention of diseases or adverse effects caused by environmental exposure to chemical and physical agents. This project specifically supports an interagency agreement between the National Institute of Environmental Health Sciences (NlEHS) of the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) The National Toxicology Program (NTP) is an interagency program headquarted at NIEHS and was established by the Secretary of Health and Human Services to provide information about potentially toxic chemicals to regulatory and research agencies and the public, coordinate toxicology research and testing activities and strengthen the science base in toxicology. This lAG addresses a need by the FDA to obtain comprehensive toxicological data on chemical and physical agents regulated by the FDA for which questions about safety existed, but where the FDA either had no legal authority to require the regulated community to provide such data or there was no sponsor for the needed testing. Potential diseases of concern that may be induced by these agents include cancer, reproductive and developmental effects, cardiovascular disease, neurological disease and effects on the immune system. Agents under evaluation using this IAG include endocrine active agents, AIDS therapeutics, dietary supplements, complementary and alternative medicines, anesthetics used in pediatric medicine, and agents that can be activated on co-exposure to UV light.

该项目的主要目标是为国家毒理学计划（NTP）的危害评估活动提供支持，这些活动旨在预防因环境暴露于化学和物理制剂而引起的疾病或不良影响。 该项目专门支持美国国立卫生研究院（NIH）的国家环境健康科学研究所（NlEHS）和美国食品药品监督管理局（FDA）之间的机构间协议 国家毒理学计划（NTP）是一个跨部门计划，总部设在NIEHS，由卫生和人类服务部部长建立，旨在向监管和研究机构以及公众提供有关潜在有毒化学品的信息，协调毒理学研究和测试活动，并加强毒理学的科学基础。 本LAG解决了FDA需要获得FDA监管的化学和物理制剂的全面毒理学数据的问题，这些制剂存在安全性问题，但FDA没有法律的权力要求监管机构提供此类数据，或者没有申办者进行所需的试验。这些物剂可能诱发的令人关切的潜在疾病包括癌症、生殖和发育影响、心血管疾病、神经系统疾病和对免疫系统的影响。 使用该IAG评估的药物包括内分泌活性药物、艾滋病治疗药物、膳食补充剂、补充和替代药物、儿科药物中使用的麻醉剂以及可在共同暴露于紫外线时活化的药物。