IGF::OT::IGFYale UniversityHHSN275201400007IHHSN27500001
IGF::OT::IGF耶鲁大学HHSN275201400007IHHSN27500001
基本信息
- 批准号:9157942
- 负责人:
- 金额:$ 0.61万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-09-28 至 2020-09-27
- 项目状态:已结题
- 来源:
- 关键词:Alcohol abuseAlcoholsAnimal ModelAnimalsBiological AssayClinicalClinical InvestigatorClinical TrialsContractsDataData ReportingDevelopmentDrug CompoundingEvaluationGoalsHumanIndividualLaboratoriesNational Institute on Alcohol Abuse and AlcoholismOutcomePharmaceutical PreparationsProgram DevelopmentSafetySubstance abuse problemSyndromeTestingTherapeuticalcohol use disorderbaseclinical research sitedrug candidatedrug developmentmeetingspre-clinicalpredictive modelingprogramsprospectivescreening
项目摘要
Screening models that are predictive of clinical outcome are essential to a medications development program. There are excellent animal and human laboratory paradigms in the alcohol and substance abuse fields. A preclinical animal model program (HHSN275201400004C and HHSN275201400005C) at the National Institute on Alcohol Abuse and Alcoholism (NIAAA) was developed to screen promising compounds using various animal models and the NIAAA Clinical Investigators Group (NCIG) program was established to conduct proof-of- concept (POC) clinical trials. Lacking in NIAAA’s therapeutic drug development pipeline is a human laboratory program which will serve to screen potential medications prior to conducting the more expensive POC clinical trials. The overarching goal is to develop an integrated program wherein a prospective therapeutic compound would be tested across all three components of the program: pre-clinical animal models, human laboratory testing, and POC clinical trial. Initially, promising compounds would be examined in the preclinical animal model program. Those compounds which demonstrate efficacy in the preclinical assays (assuming safety and tolerability endpoints are met) would be advanced to the human laboratory screening program (HLAB). If the candidate compound demonstrates promising results in one or more of human laboratory assays underlying aspects of the alcohol ependence syndrome, then the prospective compound would be considered for evaluation in the NCIG POC clinical trials. Establishment of a human laboratory program for testing medications is a valuable, needed component in achieving an efficient and predictable medication development program and for the advancement of medications to treat Alcohol Use Disorders (AUDs).
预测临床结果的筛选模型对药物开发计划至关重要。在酒精和药物滥用领域有很好的动物和人类实验室范例。国家酒精滥用和酒精中毒研究所(NIAAA)开发了临床前动物模型计划(HHSN 275201400004C和HHSN 275201400005C),以使用各种动物模型筛选有希望的化合物,并建立了NIAAA临床研究者小组(NCIG)计划,以进行概念验证(POC)临床试验。NIAAA的治疗药物开发管道中缺乏一个人类实验室项目,该项目将在进行更昂贵的POC临床试验之前筛选潜在的药物。总体目标是开发一个综合计划,其中将在该计划的所有三个组成部分中测试前瞻性治疗化合物:临床前动物模型,人体实验室测试和POC临床试验。 最初,有前途的化合物将在临床前动物模型计划中进行检查。在临床前试验中证明有效性的化合物(假设满足安全性和耐受性终点)将进入人体实验室筛选项目(HLAB)。如果候选化合物在一种或多种酒精依赖综合征相关方面的人体实验室试验中显示出有希望的结果,则将考虑在NCIG POC临床试验中对预期化合物进行评价。建立用于测试药物的人类实验室计划是实现有效和可预测的药物开发计划以及促进治疗酒精使用障碍(AUDs)的药物的重要组成部分。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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SUCHITRA KRISHNAN-SARIN其他文献
SUCHITRA KRISHNAN-SARIN的其他文献
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{{ truncateString('SUCHITRA KRISHNAN-SARIN', 18)}}的其他基金
Project 1: Effects of Flavors on Nicotine Cfioice and Central Reward Me p175-205
项目 1:口味对尼古丁 Cfioice 和 Central Reward Me 的影响 p175-205
- 批准号:
9328046 - 财政年份:2013
- 资助金额:
$ 0.61万 - 项目类别:
Core 2: Research Training and Education p330-341
核心 2:研究培训和教育 p330-341
- 批准号:
8737867 - 财政年份:2013
- 资助金额:
$ 0.61万 - 项目类别:
Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine and Other Constituents (YCSTP)
耶鲁大学烟草产品使用和成瘾研究中心:香料、尼古丁和其他成分 (YCSTP)
- 批准号:
9932747 - 财政年份:2013
- 资助金额:
$ 0.61万 - 项目类别:
Yale Center for the Study of Tobacco Product Use and Addiction: Flavors, Nicotine and Other Constituents (YCSTP)
耶鲁大学烟草产品使用和成瘾研究中心:香料、尼古丁和其他成分 (YCSTP)
- 批准号:
10242016 - 财政年份:2013
- 资助金额:
$ 0.61万 - 项目类别:
PET imaging of Naltrexone Occupancy of Kappa Receptors in Heavy Drinkers
酗酒者纳曲酮 Kappa 受体占用情况的 PET 成像
- 批准号:
8577012 - 财政年份:2013
- 资助金额:
$ 0.61万 - 项目类别:
Project 4: Economics, Experiments and PATH Data: Creating Knowledge for p274-316
项目 4:经济学、实验和 PATH 数据:为第 274-316 页创造知识
- 批准号:
8921168 - 财政年份:2013
- 资助金额:
$ 0.61万 - 项目类别:
Project 4: Economics, Experiments and PATH Data: Creating Knowledge for p274-316
项目 4:经济学、实验和 PATH 数据:为第 274-316 页创造知识
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9328049 - 财政年份:2013
- 资助金额:
$ 0.61万 - 项目类别:
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