Commentary to provide context and explain significance of research is sometimes just as important as the research itself. That’s why our experts make it a priority to provide you with helpful content distilled from the many years of experience our team has accumulated. The Drug Development Insights blog contains overviews and deep dives into the drug metabolism and pharmacokinetics topics you care about—regulatory expectations, risk assessment, safety considerations, scientific innovation, study design elements, interpretation of results, and more. Explore our entries chronologically or by category to get insight into the many pieces of your drug’s development.
Drug Development Blog
KC Business Journal: KCK company helps Big Pharma save money at the molecular level
Moving a new drug from lab to market is difficult, time-consuming and expensive for any size pharmaceutical or biotechnology company....
Meet the Scientist: Andrea Wolff
At XenoTech, we pride ourselves on our 3S Principles – the values and standards that guide our businesses and shape...
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...
Meet the Scientist: Mark Horrigan
Continuing our effort to put faces to the names of some of the scientists you interact with at XenoTech, we...
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 You Need to Know About Micro-Autoradiography (mARG) Distribution Studies
In vivo determination of drug localization in tissue can be uniquely informative to drug developers investigating distribution within the context of...
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...
DDSC In Vivo ADME Expertise Providing Cost Savings
ADME studies are a vital part of the drug development process, and therefore, deciding where and how to perform these studies...
Mass Balance Studies: What You Need and Why You Need It
In vivo mass balance studies are an important element of nonclinical drug development, to inform first in-human (FIH) studies and to...
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...
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