Regulatory Acceptance of Freeze-Thaw Stability Data
Regulatory Acceptance of Freeze-Thaw Stability Data Regulatory Acceptance of Freeze-Thaw Stability Data in Pharmaceutical Submissions Freeze-thaw stability data are a critical component of pharmaceutical stability programs, particularly for temperature-sensitive products such as biologics, injectables, and vaccines. Regulatory agencies across the globe, including the FDA, EMA, and WHO PQ, expect freeze-thaw studies to support storage claims,…
Read More “Regulatory Acceptance of Freeze-Thaw Stability Data” »