IGF::OT::IGFYale UniversityHHSN275201400007IHHSN27500001

预测临床结果的筛选模型对药物开发项目至关重要。在酒精和药物滥用领域有优秀的动物和人类实验范例。在美国国家酒精滥用和酒精中毒研究所（NIAAA）建立了临床前动物模型项目（HHSN275201400004C和HHSN275201400005C），利用各种动物模型筛选有希望的化合物，并建立了NIAAA临床研究小组（NCIG）项目进行概念验证（POC）临床试验。NIAAA的治疗药物开发渠道中缺乏一个人体实验室项目，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项目，其中一个前瞻性治疗化合物将在该项目的所有三个组成部分进行测试：临床前动物模型、人体实验室测试和POC临床试验。最初，有希望的化合物将在临床前动物模型程序中进行检测。那些在临床前试验中证明有效的化合物（假设满足安全性和耐受性终点）将被推进到人类实验室筛选程序（HLAB）。如果候选化合物在酒精依赖综合征的一个或多个人体实验室分析中显示出有希望的结果，那么该候选化合物将被考虑在NCIG POC临床试验中进行评估。建立人体实验室程序来测试药物是实现有效和可预测的药物开发程序和推进治疗酒精使用障碍（AUDs）的药物的一个有价值和必要的组成部分。

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).