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What is GL58 St7corr 2 about?

The VICH GL 58 guideline, adopted in November 2019, provides stability testing protocols for new veterinary drug substances and medicinal products in Climatic Zones III and IV. It outlines specific storage conditions and testing durations necessary for regulatory submissions in these regions, emphasizing the importance of adapting to varying climatic conditions. The guideline serves as an annex to the existing VICH stability guidelines, ensuring harmonization in the stability data package required for regis

Author

Thượng Thị Thái Ngân

Language

EN