Enzyme Inhibition
ADME/PK & DDI Best Practices Industry Survey Results & Infographic
- Drug Metabolism
- September 12, 2021
- Michael Millhollen
With over 3500 respondents, only 4% of respondents said they had never experienced any repercussions from postponing these studies...
Drug-Drug Interaction (DDI) Prediction Models Following In Vitro Studies in Preclinical Development
- Drug Drug Interactions (DDI)
- August 12, 2020
- Madison Esely-Kohlman, Dr. Pallavi Limaye, Andrea Wolff, Dr. Maciej Czerwinski
In preclinical development, a drug will be evaluated for potential to cause a drug-drug interaction (DDI) using in vitro experiments and then calculations that...
ADME and Drug-Drug Interactions for the Toxicologist
- Drug Drug Interactions (DDI)
- April 28, 2020
- Madison Esely-Kohlman
Highlights from the recent webinar presented by our newest expert consultant, Dr. Pallavi Limaye In her recent webinar (now available for...
In Vitro Evaluation of Drug-Drug Interaction (DDI) Potential
- Enzyme Inhibition
- March 24, 2020
- Madison Esely-Kohlman, Zachary Mitts, Dr. Joanna Barbara
In its most recent in vitro drug interaction guidance update, the US Food and Drug Administration (FDA) emphasized harmony with the...
Four ways to optimize preclinical in vitro data to mitigate risk of late-stage clinical failure
- Consultancy
- March 9, 2020
- Madison Esely-Kohlman
1. Collect high-quality data to make informed, confident go/no go decisions for moving your drug candidate forward If you need...
Timing of In Vitro Studies: Early, Thorough ADME for Your Compound’s Success
- Regulatory Guidance
- February 13, 2020
- Madison Esely-Kohlman, Dr. Chris Bohl, Greg Loewen
Beyond the need for evidence that a drug works, Food and Drug Administration (FDA) and other regulatory bodies around the...
What In Vitro Metabolism and DDI Studies Do I Actually Need?
- Regulatory Guidance
- November 25, 2019
- Madison Esely-Kohlman, Greg Loewen
Though there is no ‘roadmap’ spelling out required studies to achieve regulatory approval for clinical entry, a drug candidate’s metabolism...
How to Choose the Right Test Systems for Your DMPK Studies
- Test Systems & Methods
- September 12, 2019
- Dr. Chris Bohl, Madison Esely-Kohlman
Test systems for DMPK in vitro studies are part of the very foundation of our company. Our labs were borne of...
To GLP or not to GLP?
- Regulatory Guidance
- October 5, 2018
- Scott Hickman, Dr. Brian Ogilvie, Tim Patterson
That is the question. . . Knowing the answer may save you time and money Good Laboratory Practices (GLP) are...
UGT Activities, Concomitant Drugs, and DDI
- Enzyme Induction
- June 20, 2017
- Michael Millhollen
If you have concerns about how your compound may affect UDP-glucuronosyltransferase (UGT) induction and/or inhibition when combined with other therapeutic...
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