QbD for pediatric oral lyophilisates development: risk assessment followed by screening and optimization.
Tibor CasianSonia IurianCatalina BogdanLucia Maria RusMirela MoldovanIoan TomuţăPublished in: Drug development and industrial pharmacy (2017)
Combining FMEA and DoE allowed the science based development of a product with respect to the defined quality target profile by providing better insights on the relevant parameters throughout development process. The utility of risk management tools in pharmaceutical development was demonstrated.