This document addresses the recommendations on the data to 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.

Keywords: Stability, dosage forms, line extension

Current effective version

ICH: Q 1 C: Stability testing: Requirements for new dosage forms - Step 5

AdoptedLegal effective date: Reference Number: CPMP/ICH/280/95

English (EN) (108.52 KB - PDF)

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