A Design Space Verification Protocol for A Small Molecule Drug Substance

Timothy J. N. Watson, Holly Bonsignore, Eileen A. Callaghan-Manning,Stephen T. Colgan, Paul Fitzsimons, Thomas P. Garcia, John G. Groskoph, Michael P. Lynch,Roger Nosal,Megan E. McMahon,Robert A. Singer,Nicholas M. Thomson,Gregory W. Sluggett, Darren J. Schulz, Shirley Twohig

Journal of Pharmaceutical Innovation（2013）

Cited 5|Views12

Key words

Design Space,Critical Quality Attribute,Regulatory Submission,Entire Design Space,Full Production Scale

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