药物临床试验法规与技术规范 .pdfVIP

药物临床试验法规与技术规范

索引

一．国际政策法规与技术规范·····························································2·

法规及规范······························································错误!未定义书签。

指导原则································································································2·

（一）美国FDA指导原则··································································2·

（二）欧盟EMEA指导原则·································································7

二．国内政策法规与技术规范····························································10

法规·······································································································10

指导原则·······························································································12

（一）化学药物···················································································12

（二）中药、天然药物········································································15

（三）生物制品···················································································16

1

一．国际政策法规与技术规范

1.赫尔辛基宣言2013中文版

2.赫尔辛基宣言2013英文版

3.涉及人的生物医学研究的国际伦理准则2002

4.生物医学研究审查伦理委员会操作指南2000

5.ICH-GCP

指导原则

（一）美国FDA指导原则

1.以哺乳期妇女为受试人群的临床研究指导原则（GuidanceforIndustryClinicalLactation

Studies–StudyDesign,DataAnalysis,andRecommendationsforLabeling）(2005)

2.药物相互作用研究指导原则（GuidelineontheInvestigationofDrugInteractions）(2006)

3.药物代谢和药物相互作用的体外试验指导原则(1997)

4.药物暴露量-效应关系研究指导原则(2003)

5.儿童药代动力学研究基本要点（GUIDELINEONTHEROLEOFPHARMACOKINETICSINTHE

DEVELOPMENTOFMEDICINALPRODUCTSINTHEPAEDIATRICPOPULATION）(1998)

6.药物体内代谢和药物相互作用研究指导原则(1997)

7.肝功能不全患者的药代动力学研究指导原则（PharmacokineticsinPatientswithImpaired

HepaticFunction:StudyDesign,DataAnalysis,andImpactonDosingandLabeling）(2003)

8.肾功能不全患者的药代动力学研究指导原则（Guidance