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Development of a Control Strategy for Benzene Impurity in HPMCAS-Stabilized Spray-Dried Dispersion Drug Products Using a Science-Based and Risk-Based Approach
Yue, Hongfei, Nicholson, Sarah J., Young, Joel D., Hsieh, Daniel, Ketner, Rodney J., Hall, Robert G., Sackett, Jeremy, Banks, Elizabeth C., Castoro, John A., Randazzo, Michael E.Volume:
32
Language:
english
Journal:
Pharmaceutical Research
DOI:
10.1007/s11095-015-1649-7
Date:
August, 2015
File:
PDF, 793 KB
english, 2015