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Eudralex Volume 3 Stability Testing: Requirements for New Dosage Forms (ICH Q1C) CPMP/ICH/ 280/95-ICH Q1C

Short Title:


This document is an annex to the ICH parent stability guideline and addresses the recommendations on the data which should be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new active substances and medicinal products.

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