Qualification of Impurities Based on Metabolite Data.

Lars Weidolf,Thomas Andersson,Joel P. Bercu,Andreas Brink,Susanne Glowienke,James Harvey,Martin A. Hayes, Pascale Jacques,Chuang Lu,Nenad Manevski,Wolfgang Muster,Raphael Nudelman,Ron Ogilvie,Jenny Ottosson,Andrew Teasdale,Bruce Trela

Regulatory Toxicology and Pharmacology（2020）

引用 13|浏览44

关键词

Impurity,Degradation product,Drug metabolite,Qualification,Specification limit,ICH Q3A(R2),ICH Q3B(R2),Significant metabolite,3R,Maximum theoretical concentration

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