Broughton Whitepaper: Designing a Bespoke Stability Study

In this whitepaper, we discuss the stability studies that may be performed during pharmaceutical development and in support of a regulatory dossier to support the licensing of a medicinal drug product. This whitepaper examines the specific design features of stability studies that should be considered to ensure a study is created bespoke for the product. This review includes the analytical methodology that should be considered, and the evaluation of stability data, which is critically important in substantiating a drug product's shelf life and supporting a regulatory dossier.