Best Practices in Customizing Protocols for Drug-Specific Stability Studies
In pharmaceutical development, one-size-fits-all rarely applies to stability studies. Each drug product—whether a biologic, a modified-release capsule, or a pediatric syrup—requires a stability protocol aligned with its unique formulation, intended use, and regulatory expectations. This article explores best practices for customizing stability protocols across diverse drug types to ensure compliance, minimize risk, and optimize product…
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