ICH指导原则分享-Q1e 稳定性数据评价 EVALUATION OF STABILITY DATA Draft ICH Consensus Guideline Released for Consultation, 7 February 2002, at Step 2 of the ICH Process TABLE OF CONTENTS 1. INTRODUCTION....................................................................................................1 1.1 Objectives of the Guidelines.............................................................................. 1 1.2 Background ........................................................................................................ 1 1.3 Scope of the Guideline ....................................................................................... 1 2. GUIDELINES..........................................................................................................1 2.1 General Principles ............................................................................................. 1 2.2 Data Presentation.............................................................................................. 2 2.3 Extrapolation ..................................................................................................... 2 2.4 Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products Intended for “Room Temperature” Storage .............. 3 2.5 Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products Intended for Storage Below “Room Temperature” ... 5
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