Transcription of EVALUATION FOR STABILITY DATA - ICH Official …
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EVALUATION FOR STABILITY DATA - ICH Official …
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN. USE. ICH HARMONISED TRIPARTITE GUIDELINE. EVALUATION FOR STABILITY data . Q1E. Current Step 4 version dated 6 February 2003. This 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. Q1E. Document History New First Codification History Date Codification November 2005. Q1E Approval by the Steering Committee under Step 2 and 6 February Q1E.
EVALUATION OF STABILITY DATA 1. INTRODUCTION 1.1 Objectives of the Guideline This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guideline “Q1A(R)
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