ADME 101™
How can in vitro and in vivo studies help me understand my drug’s clearance?
Systemic clearance, denoting how much drug is cleared from a volume of blood per unit of time, is of critical...
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...
How Can I Make Sure My Data Meets Regulatory Expectations?
Regulatory authorities publish updated guidance documents that share their expectations for endpoints and test systems with drug developers, but sometimes it is difficult to...
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...
I Have My Data… Now What?
As a drug moves through the development pipeline, it undergoes a rigorous battery of safety assessments to prove it will...
The FDA has requested follow-up data… how do I fill in the gaps?
Because each new drug is unique in characteristics, such as chemical structure, mechanism of action, and physicochemical properties, there can...
How to Choose the Right Test Systems for Your DMPK Studies
Test systems for DMPK in vitro studies are part of the very foundation of our company. Our labs were borne of...
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