Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis

Sanyal Arun J.; Miller Veronica

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Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis

机译：酒精性和非酒精性脂肪性肝炎的监管科学和药物批准

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来源
《Gastroenterology》 |2016年第8期|共5页
作者
Sanyal Arun J.; Miller Veronica;
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原文格式 PDF
正文语种 eng
中图分类消化系及腹部疾病;
关键词
Alcoholic Hepatitis; Nonalcoholic Steatohepatitis; Regulatory Science; Drug Approval; Clinical Trials; End Points; Trial Design; Drug Development;

机译：酒精性肝炎;非酒精性脂肪性肝炎;法规科学;药物批准;临床试验;终点;试验设计;药物开发;

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1. Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis [J] . Sanyal Arun J., Miller Veronica Gastroenterology . 2016,第8期

机译：酒精性和非酒精性脂肪性肝炎的监管科学和药物批准
2. Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science [J] . Siddiqui Mohammad Shadab, Harrison Stephen A., Abdelmalek Manal F., Hepatology: Official Journal of the American Association for the Study of Liver Diseases . 2018,第5期

机译：通过监管科学晶状体晶体晶状体术治疗非酒精性脂肪性肝炎临床试验中临床点肠癌的病例定义
3. Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science [J] . Siddiqui Mohammad Shadab, Harrison Stephen A., Abdelmalek Manal F., Fortschritte der Physik . 2018,第5期

机译：通过监管科学晶状体晶体晶状体对非酒精性脂肪性肝炎临床试验临床试验终点的病例定义
4. HOW THE SOCIAL SCIENCES HELP NUCLEAR PROJECTS GAIN REGULATORY APPROVALS AND PROJECT SUCCESS [C] . Danya Braun International High-Level Radioactive Waste Management 2019 . 2019

机译：社会科学如何帮助获得核项目的监管批准和项目成功
5. Meta-Analysis to Identify and Evaluate Factors Associated with Regulatory Approval of Orphan Drugs (OD) to Develop an Algorithm for Predicting Regulatory Approval (Success) and to Develop a Standardized Tool to Improve Orphan Drug Portfolio Decision-Making [D] . Florent, Milky C. 2019

机译：荟萃分析，以识别和评估与孤儿药物监管批准（OD）相关的因素，以开发预测监管批准（成功）的算法，并开发标准化工具以改善孤儿药物投资组合决策
6. REGULATORY SCIENCE AND DRUG APPROVAL FOR ALCOHOLIC AND NONALCOHOLIC STEATOHEPATITIS [O] . Arun J. Sanyal, Veronica Miller -1

机译：酒精和非酒精性脂肪肝的监管科学和药物批准
7. Non-Alcoholic Steatohepatitis: Limited Available Treatment Options but Promising Drugs in Development and Recent Progress Towards a Regulatory Approval Pathway [O] . 2015

机译：非酒精性脂肪性肝炎：有限的可用治疗选择，但有发展前景的药物和监管批准途径的最新进展
8. New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts [R] . 2006

机译：新药开发：科学，商业，监管和知识产权问题被列为妨碍药物开发的努力

Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis

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