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

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

https://www.gmp-compliance.org/files/guidemgr/028095en.pdf

Origin/Publisher:

EMEA

Content:
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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