Enzyme Induction
ADME and Drug-Drug Interactions for the Toxicologist
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
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
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
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?
Though there is no ‘roadmap’ spelling out required studies to achieve regulatory approval for clinical entry, a drug candidate’s metabolism...
Can CYP3A4 Induction Predict P-glycoprotein Induction in DDI Studies?
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
Why do induction studies? Induction potential is an important piece of the drug-drug interaction (DDI) component of an IND submission. Simply put, we...
IQ Induction Working Group Publishes Recommendations for Data Interpretation of In Vitro Induction – Focus on CYP3A4 mRNA
SEKISUI XenoTech is proud to have made contributions to the paper entitled, “Considerations from the IQ Induction Working Group in...
UGT Activities, Concomitant Drugs, and DDI
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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