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CPMP/ICH/420/02. ICH Topic Q 1 E. Evaluation of Stability Data. Step 5. NOTE FOR GUIDANCE ON. EVALUATION OF STABILITY DATA. (CPMP/ICH/420/02). TRANSMISSION TO CPMP .. be conducted to address the effect of short-term excursions outside the proposed label storage condition (e.g., during shipping or
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25 Sep 2013 ICH has edited guidelines to harmonize testing conditions and methods to determine storage conditions and shelf-lives. The standard program starts with stress tests to determine the degradation pathways and the stability indicating methods, and describes long-term and accelerated conditions testing.
2 Jan 2010 Stability v1.doc. March 2004. 1. SADC GUIDELINE FOR STABILITY TESTING. 2004. This guideline is intended to provide requirements to applicants wishing to submit applications for the registration .. the effect of short term excursions outside the label storage condition, e.g. during shipping or handling.
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