Development of a Control Strategy for Benzene Impurity in HPMCAS-Stabilized Spray-Dried Dispersion Drug Products Using a Science-Based and Risk-Based Approach

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作者： Yue, Hongfei ^[1] ; Nicholson, Sarah J. ^[2] ; Young, Joel D. ^[3] ; Hsieh, Daniel ^[4] ; Ketner, Rodney J. ^[5] ; Hall, Robert G. ^[6] ; Sackett, Jeremy ; Banks, Elizabeth C. ; Castoro, John A. ; Randazzo, Michael E.

作者单位： Bristol Myers Squibb Co, Analyt & Bioanalyt Dev, New Brunswick, NJ 08903 USA ^[1] Bend Res Inc, Bend, OR 97701 USA ^[2] Bristol Myers Squibb Co, Chem Dev, New Brunswick, NJ 08903 USA ^[3] Bristol Myers Squibb Co, Drug Prod Sci & Technol, New Brunswick, NJ 08903 USA ^[4] Bristol Myers Squibb Co, Analyt & Bioanalyt Dev, Moreton CH46 1QW, Merseyside, England ^[5] Bristol Myers Squibb Co, Drug Prod Sci & Technol, Moreton CH46 1QW, Merseyside, England ^[6]

关键词 benzene control impurity solvent spray-dried dispersion (SDD)

发布时间 2017-05-11

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