Efficacy Guidelines
有效性
编号阶段内容
E1Step 5The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions
对非危及生命的疾病的长期治疗药物进行临床安全性评估的人群暴露程度
E2AStep 5Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
临床安全性数据管理:快速报告的定义和标准
E2B(R3)Step 5Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
临床安全性数据管理:个体病例安全性报告传递的数据要素
E2B(R3) IWGStep 5Implementation: Electronic Transmission of Individual Case Safety Reports
关于E2B(R3)实施的问与答
E2C(R2)Step 5Periodic Benefit-Risk Evaluation Report
上市药品定期风险效益评估报告
E2C(R2) Q&AsStep 5Questions & Answers: Periodic Benefit-Risk Evaluation Report
上市药品定期风险效益评估报告的问与答
E2DStep 5Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
批准后的安全数据管理:快速报告的定义和标准
E2EStep 5Pharmacovigilance Planning
药物警戒计划
E2FStep 5Development Safety Update Report
研发安全性更新报告
E3Step 5Structure and Content of Clinical Study Reports
临床研究报告的结构与内容
E3 Q&As (R1)Step 5Questions & Answers: Structure and Content of Clinical Study Reports
临床研究报告的结构与内容问与答
E4Step 5Dose-Response Information to Support Drug Registration
新药注册所需的量-效关系资料
E5(R1)Step 5Ethnic Factors in the Acceptability of Foreign Clinical Data
引入海外临床数据时要考虑的种族因素
E5 Q&As (R1)Step 5Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data
引入海外临床数据时要考虑的种族因素的问与答
E6(R1)Step 5Good Clinical Practice
药品临床研究规范(GCP)一致性指导原则
E6(R2)Step 5Integrated Addendum to Good Clinical Practice (GCP)
2016版ICH GCP
E7Step 5Studies in Support of Special Populations: Geriatrics
老年人群的临床研究
E7 Q&AsStep 5Questions & Answers: Studies in Support of Special Populations : Geriatrics
老年人群的临床研究的问与答
E8Step 5General Considerations for Clinical Trials
临床试验的一般考虑
E9Step 5Statistical Principles for Clinical Trials
临床试验统计原则
E9(R1)Step 1Addendum: Statistical Principles for Clinical Trials
E9附录
E10Step 5Choice of Control Group and Related Issues in Clinical Trials
临床试验的对照组选择及相关问题
E11Step 5Clinical Investigation of Medicinal Products in the Pediatric Population
儿童用药品的临床调查
E11(R1)Step 3Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
E11附录
E12Step 5Principles for Clinical Evaluation of New Antihypertensive Drugs
新抗高血压药的临床评价原则
E14Step 5The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
非抗心律失常药物致QT/QTc间期延长及潜在心律失常作用的临床评价
E14 Q&As (R3)Step 5Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
E14的问与答
E14/S7BStep 1Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation
QT/QTc间期延长的临床和非临床评价讨论组
E15Step 5Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
基因组生物标记物、药物基因组学、遗传药理学、基因组数据和样本编码分类的定义
E16Step 5Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions
与药物或生物技术产品相关的生物标记物研发:申请资料的内容、结构和格式
E17Step 3General principle on planning/designing Multi-Regional Clinical Trials
国际多中心临床试验计划与设计原则
E18Step 3Genomic Sampling and Management of Genomic Data
基因组样品采集和基因组数据管理指南
 
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