Enzyme Induction
When, Why and How to Conduct CYP2C Induction Studies
- Enzyme Induction
- April 8, 2022
- Dr. Andrew G. Taylor, Rebecca Campbell, Michael Millhollen, Lucy Fahler
Over the years, we have received a lot of questions about cytochrome P450 (CYP) 2C induction studies. In February of...
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...
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...
Can CYP3A4 Induction Predict P-glycoprotein Induction in DDI Studies?
- Enzyme Induction
- August 20, 2019
- Shanté Jackson, Madison Esely-Kohlman
Generally, a drug’s effects on enzyme and transporter activity are examined independently in a drug development program, but what if...
In Vitro Induction Studies: Elements of Design and Important Considerations in Data Analysis
- Enzyme Induction
- May 13, 2019
- Madison Esely-Kohlman, Dr. Joanna Barbara, Rebecca Campbell
Why do induction studies? Induction potential is an important piece of the drug-drug interaction (DDI) component of an IND submission. Simply put, we...
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