October 2018

October Presentations on In Vitro Effects of Biologics on CYP Enzymes and Regulatory DDI Guidances

Author: Michael Millhollen Posted: 26 October 2018

Dr. Brian Ogilvie presented on In vitro Direct and Cytokine-Mediated Effects of Therapeutic Peptides and other Biologics on CYP Enzymes at the Peptide ADME Discussion Group Workshop and a Comparison Between the US FDA, EMA and Japan PMDA In Vitro DDI Guidances: Are we Closer to Harmonization? at the DMDG-SPS Joint Meeting in Gothenburg, Sweden...

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To GLP, or Not To GLP?

Author: Scott Hickman, Dr. Brian Ogilvie, Tim Patterson Posted: 05 October 2018

In vitro drug interaction studies do not necessarily need to be performed under GLP conditions. To learn more — and probably save time and considerable money — read this article...

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New Recommendation: Evaluate NMEs for OCT1 Transporter-Mediated DDI Potential

Author: Andrea Wolff, Brian Ogilvie Posted: 01 October 2018

Patient-to-patient variability in the activity of liver transporter OCT1 turns out to be a huge factor in the therapeutic activity and clearance of several commonly prescribed drugs. Dr. Brian Ogilvie presented a case for in vitro OCT1 transporter studies in 2017 based on the effects of polymorphisms on sumatriptan, and now the International Transporter Consortium (ITC) is weighing in. Learn some of the highlights of their August 2018 recommendations (like why OCT1 studies matter)...

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