Early Clinical Drug Product Shelf-Life Setting Using Accelerated Predictive Stability and Metabolite Data for Impurity Qualification: A Case Study

Jenny E. Ottosson, Angela Ku,Magnus Fransson,Carina Leandersson,Lars Weidolf, Jufang Wu Ludvigsson,Magnus Klarqvist

Journal of Pharmaceutical Sciences（2024）

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关键词

Degradation product(s),Metabolism,Chemical stability,Stability,Chromatography,Formulation,Absorption,Distribution,and,Excretion (ADME) (1 i listan),Drug design,Oxidation(s),Regulatory science

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