Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
Commentary|Videos|August 18, 2023
How Breakthrough Technologies are Shaping Clinical Trials with Stuart Malcolm
Author(s)Grant Playter
Stuart Malcolm, head of Standards, Efficiency, and Automation at Veramed, speaks on how advancing technologies are shaping clinical trials.
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Stuart Malcolm, head of Standards, Efficiency, and Automation at Veramed, spoke with Grant Playter, associate editor, on-site at the REV4 data conference in New York City. Stuart spoke at length on the intersection of statistical programming and clinical trials and how the industry plans to leverage data, automation, visualization, and artificial intelligence technologies going forward.
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Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.
Celtic Renewables won the CPHI Award for Sustainable Pharma Excellence for its green chemicals used in pharmaceutical manufacturing. Bettina Brierley, chief commercial officer, talks about the adoption, capacity, and pricing of biosolvents.
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CPHI Award winner, Pauline van der Wijst-Janssen, PhD, product development manager and global technical lead at DFE Pharma, explains excipient variability and excipients’ role in continuous manufacturing.
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