Regulatory Feedback on Shelf-Life Assignments from Stability Data
Regulatory Feedback on Shelf-Life Assignments from Stability Data Understanding Regulatory Feedback on Shelf-Life Assignments Based on Stability Data Assigning an accurate and defensible shelf life is one of the most critical outcomes of pharmaceutical stability studies. Regulatory authorities like the USFDA, EMA, CDSCO, and WHO rigorously assess submitted stability data to determine if it supports…
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