The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
Elizabeth Hewitt
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Elizabeth Hewitt is senior scientist I, Elizabeth.Hewitt@mpi.com,at Millennium Pharmaceuticals, Inc., 40 Landsdowne St., Cambridge, MA 02144, USA.
Articles by Elizabeth Hewitt
In this article, the authors demonstrate that a normal-phase chromatographic method was stability-indicating for a water-sensitive prodrug. The stress conditions using aqueous and non-aqueous conditions were also compared to understand the information obtained with each approach.
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