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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.

as temperature, humidity and light, and enables recommended storage conditions, re-test ... the goodness of fit of any mathematical model, batch size, existence of supportive data etc. ... The use of terms such as 'ambient conditions' or 'room temperature' is unacceptable. A re-test period should be derived from the stability information.

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