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
FAQ: Using Plateable Hepatocytes in In Vitro Assays
Plateable hepatocytes are often used for induction studies and to research metabolism, biochemistry, virology, host/pathogen interactions, and cell biology. Here,...
Ask Me Anything About In Vitro ADME, Drug-Drug Interaction Approaches and Strategies
Last month, Dr. Joanna Barbara joined AAPS for an online Q&A in their ongoing “Ask the Experts” series. As regulatory...
Are in vitro drug metabolism and drug-drug interaction studies critical for an IND?
A Guide to What, Why & When to Conduct ADME Studies When drug developers are preparing their IND, drug metabolism...
4 Ways De-Risking Maximizes Compound Value
Since most new drugs fail because of ADME/Tox, you can add considerable value to your compound by conducting early in...
New FDA Draft Guidance “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics” – XenoTech’s perspective on in vitro DDI testing
The FDA has released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”...
Spotlight on Efflux and Uptake Drug Transporters in In Vitro Drug-Drug Interaction Studies
What are drug transporters? Drug transporters are membrane-bound proteins that assist in the movement of drugs into or out of...
When, Why and How to Conduct CYP2C Induction Studies
Over the years, we have received a lot of questions about cytochrome P450 (CYP) 2C induction studies. In February of...
Which Hepatocytes Should I Use for What Studies?
Primary hepatocytes are considered the gold standard for ADME/DMPK studies because they are the most representative in vitro test system. However, not all hepatocyte formats…
Meet the Scientist: Alex Wakefield
In this month’s installment of our Meet the Scientist series we wanted to feature one of our team of talented...
Why Do Most Polled Researchers Run Red Blood Cell Partitioning Studies with Plasma Protein Binding?
Many compounds bind to or diffuse into red blood cells (RBCs), which can significantly impact clearance and cause inaccuracies in PK calculations...
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