Designing Freeze-Thaw Studies for Regulatory Filing Compliance
Designing Freeze-Thaw Studies for Regulatory Filing Compliance Designing Freeze-Thaw Studies for Regulatory Filing Compliance in Pharmaceuticals Freeze-thaw studies are a critical element in pharmaceutical stability testing, particularly for temperature-sensitive biologics, vaccines, injectables, and cold-chain products. Regulatory authorities—including the FDA, EMA, and WHO PQ—require robust and scientifically justified freeze-thaw protocols to support stability claims and label…
Read More “Designing Freeze-Thaw Studies for Regulatory Filing Compliance” »