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Poor aqueous solubility represents a major hurdle in achieving adequate oral bioavailability for a large percentage of drug compounds in drug development nowadays.
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How to Identify Critical Quality Attributes and Critical Process Parameters Jennifer Maguire, Ph.D. Daniel Peng, Ph.D. Office of Process and Facility (OPF)
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The ICH quality vision introduced the concept of quality by design (QbD), which requires a greater understanding of the raw material attributes, of process parameters ...