Drug Drug Interactions (DDI)
Are in vitro drug metabolism and drug-drug interaction studies critical for an IND?
- ADME 101™
- November 1, 2022
- Dr. Andrew G. Taylor, Michael Millhollen, Isis Smith, Amara Millhollen
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
- ADME 101™
- August 31, 2022
- Michael Millhollen
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New FDA Draft Guidance “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics” – XenoTech’s perspective on in vitro DDI testing
- Regulatory Guidance
- July 11, 2022
- Dr. Maciej Czerwinski, Dr. Pallavi Limaye, Dr. Brian Ogilvie
The FDA has released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”...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
- Drug Transporters
- June 23, 2022
- Dr. Andrew G. Taylor, Michael Millhollen, Isis Smith
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
- 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...
Why Do Most Polled Researchers Run Red Blood Cell Partitioning Studies with Plasma Protein Binding?
- Drug Drug Interactions (DDI)
- January 25, 2022
- Dr. Steven McGreal, Michael Millhollen
Many compounds bind to or diffuse into red blood cells (RBCs), which can significantly impact clearance and cause inaccuracies in PK calculations...
Highlights from the 2021 Marbach Drug-Drug Interaction Workshop
- Drug Drug Interactions (DDI)
- January 11, 2022
- Darina Hynes
Reflecting on the virtual conferences in 2021, I would like to look back at some of the highlights from the...
2021 Service Expansions: Microsomal Protein Binding and Red Blood Cell Partitioning
- Updated Offerings
- January 3, 2022
- Michael Millhollen
Over the course of 2021, we expanded access to two important and related study offerings at our US laboratory headquarters....
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...
Four Ways CROs Drive Innovation for Improved In Vitro Drug Metabolism and Pharmacokinetics (DMPK) Studies
- Drug Metabolism
- May 17, 2021
- Darina Hynes, Madison Esely-Kohlman
Agility and focused growth allow drug developers to outsource expertise and benefit the industry at-large by fostering innovation. Panelists at the 2021 Annual DMDG Meeting…
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