A comparison of drug substance predicted chemical stability with ICH compliant stability studies
Drug Development and Industrial Pharmacy2018Vol. 45(3), pp. 379–386
Citations Over Time
Helen Elizabeth Williams, Jonathan Bright, Emily Roddy, Andrew M. Poulton, Steve Cosgrove, Fitzhugh L. Turner, Pamela Harrison, Alan Brookes, E. MacDougall, Alexander Abbott, Carolyn Gordon
Abstract
This comparison of ASAP predictions and ICH compliant stability data has demonstrated the ability of well-designed ASAP studies to predict the long-term chemical stability of drug substances.
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