Regulatory Justifications for Omission of Intermediate Condition Studies
Regulatory Justifications for Omission of Intermediate Condition Studies Regulatory Justifications for Omitting Intermediate Stability Studies in Pharmaceutical Development Intermediate condition studies—typically performed at 30°C ± 2°C / 65% RH ± 5%—are a critical element in pharmaceutical stability programs, especially when accelerated studies show significant change. However, there are scenarios where omitting intermediate condition testing is…
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