Transcription of 32 1.4 Stability Workshpo ICH Q1D C - IKEV
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32 1.4 Stability Workshpo ICH Q1D C - IKEV
ICHQ1D C ICH Q1D Guideline Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products ICH Step 4 Comments for its application ICHQ1D C 43 1. Introduction Objectives of the Guideline Recommendations for application of bracketing and matrixing Background Q1A(R2) mentions only possibility Scope of the Guideline Guidance on study designs Specific priniciples for applications Sample designs for illustrative purposes 2. Guidelines General Full study design: samples for every combination, all design factors tested at all time points Reduced design ability to adequately predict retest period or shelf life Risk assessment, shorter shelf life possible Change to full testing or less reduced design can be considered.
ICHQ1D C 42 1.4 ICH Q1D Guideline Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products ICH Step 4 Comments for its application
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