文档标签: ICH guidelines 临床 试验 管理 规范 英文 医学 系统标签: ich guidelines 临床 investigational emea 试验 TheEuropeanAgencyfortheEvaluationofMedicinalProducts 7WestferryCircus,CanaryWharf,London,E144HB,UK Tel.(44-20)74188400Fax(44-20)74188613 E-mail:mail@emea.eu.inthttp://.emea.eu.int ©...
E9_Guideline-Statistical Principles for Clinical Trials 本指南主要介绍ICH中关于临床试验的统计方法,试验组设计,因素和终点设计,数据清洗,数据验证,结果统计等等多个方面。 本文源自ICH官网,中文机翻采用google翻译 中英文双语对照文件,英文原始文件 全文下载链接在下方 ICH-E9pan.quark.cn/s/c9b9f32e560e发布...
E17Multi-RegionalClinicalTrials(国际多中心临床试验) 2 E18GenomicSampling(基因组采样) MultidisciplinaryGuidelines 多学科综合 M1MedDRATerminology(监管活动医学术语) M2ElectronicStandards(电子标准) M3NonclinicalSafetyStudies(非临床安全性研究) M4CommonTechnicalDocument(通用技术文件) DataElementsandStandardsforDrugDictio...
ICH协调指导原则E17 General principle on planning and Designing Multi-Regional Clinical Trials.pdf,INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE GENERAL PRINCIPLES FOR PLANNING
risk-based monitoring resources • Sensible Guidelines for the Conduct of Clinical Trials meetings, 2007-2012 • OECD Recommendation on the Governance of Clinical Trials 2013 • Risk proportionate approaches in clinical trials Recommendations of the expert group on clinical trials for the ...
Factors(种族因素)E6GoodClinicalPractice(药物临床研究质量管理规范)E7ClinicalTrialsinGeriatricPopulation(老年人群的临床试验)E8GeneralConsiderationsforClinicalTrials(临床试验的一般考虑)E9StatisticalPrinciplesforClinicalTrials(临床试验的统计原则)E10ChoiceofControlGroupinClinicalTrials(临床试验中对照组的选取)E11ClinicalTr...
The conduct of clinical trials in Japan has changed with the implementation of the International Conference on Harmonization and Good Clinical Practice (GCP) guidelines in 1997. Even though the primary objective of the guidelines is to maintain the quality of trials at an internationally acceptable le...
(2000): The International Conference on Harmonization guideline "Statistical Principles for Clinical Trials": Issues in applying the guideline in practice. Drug Inf. J., 34(2):337-348.Phillips A, Ebbutt A, France L, Morgan D. The International Conference on Harmonization guideline `Statistical...
ICH-有效性(Efficacy Guidelines)E11 Clinical Trials in Pediatric Population/儿童人群临床研究 ICH指导原则 (cde.org.cn) E11(R1):用于儿科人群的医学产品的药物临床研究 目前在说明书上明确注明可用于儿科人群的医学产品的数量有 限。本指南的目的是鼓励和促进用于儿科人群的医学产品的研发。本 指南概述了儿科...
Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline First page of article JA Lewis - 《Statistics in Medicine》 被引量: 377发表: 1999年 International Conference on Harmonisation Statistical principles for clinical trials (E9): ICH tripartite guideli...