ICHQ1E.docxVIP

ICH Q1E 稳定性数据评中英文）NTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USEICH HARMONISED?TRIPARTITE?GUIDELINEEVALUATION FOR?STABILITY?DATA稳定性数据评估Q1ECurrent?Step 4?versiondated 6 February 2003This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.本指南已由相应的ICH专家工作组完成，并根据ICH要求，由各法规方审核。本版本为最终版本，建议ICH三方法规当局采用。Q1E Document HistoryEvaluation FOR STABILITY DATAICH Harmonised Tripartite GuidelineHaving reached Step 4of the ICH Process at the ICH Steering Committee meeting on 6 February 2003, this guideline is recommended for adoption to the three regulatory parties to ICHTABLE OF CONTENTS目录1. INTRODUCTION介绍1.1 Objectives of the Guideline 指南目的1.2 Background 背景1.3 Scope of the Guideline 指南范围2. GUIDELINES?指南2.1 General Principles.一般原则2.2 Data presentation数据展示2.3 Extrapolation外推法2.4 Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products Intended?for Room Temperature Storage室温存贮条件原料药或制剂复验期或货架期估算数据评估2.4.1No significant change at accelerated condition在加速条件下无显著变化2.4.2Significant change at accelerated condition在加速条件下有显著变化2.5 Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products Intended for Storage Below Room Temperature 低于室温存贮条件原料药或制剂复验期或货架期估算数据评估2.5.1Drug substances or products intended for storage in a refrigerator冷藏条件下存贮的原料药或制剂2.5.2Drug substances or products intended for storage in a freezer 冷冻条件下存贮的原料药或制剂2.5.3Drug substances or products intended for storage below -20°C低于-20?C下存贮的原料药或制剂2.6 General Statistical Approaches常用统计方法3. APPENDICES?附件Appendix A: Decision Tree for Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products (excluding Frozen Products)附件A：