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Search results with tag "On stability"
ICH Q5C Stability testing of Biotechnological / Biological ...
www.ich.org4 ICH Q5C - Stability testing of Biotechnological / Biological products ICH guidelines on stability • Q1A - Stability testing for new drug substances and products (R2 - 2003) •PARENT GUIDELINE. Defines the stability data package for registration of a new
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG …
www.asean.orgStability studies should include testing of those attributes of the drug product that are susceptible to change during storage and are likely to influence quality, safety and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological and microbiological attributes, preservative content (e.g. antioxidant ...