ICH Topic Q 1 A Stability Testing Guidelines: Stability ...

The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit CPMP/ICH/380/95. ICH Topic Q 1 A. Stability Testing guidelines : Stability Testing of New Drug Substances and Products Step 5. NOTE FOR GUIDANCE ON Stability Testing : Stability . Testing OF NEW DRUG SUBSTANCES AND PRODUCTS. (CPMP/ICH/380/95). [This guideline replaces relevant section of previous guideline]. APPROVAL BY CPMP December 1993. STUDIES CAN BE SUBMITTED ACCORDING TO THIS GUIDELINE January 1994. DATE FOR COMING INTO OPERATION 1 January 1998. (DOSSIERS SUBMITTED AFTER). ICH - Technical Coordination - R. Bass 7 Westferry Circus, Canary Wharf, London E14 4HB, UK. Tel: (+44-171) 418 84 11 Fax: (+44-171) 418 85 51.

CPMP/ICH/380/95 5/13 DRUG PRODUCT General The design of the stability programme for the finished product should be based on the knowledge of the behavior and properties of the drug substance and the experience gained

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