Author: wpengine
FAQ: Using Plateable Hepatocytes in In Vitro Assays
- Test Systems & Methods
- December 13, 2022
- Halee McElhaney, Lucy Fahler
Plateable hepatocytes are often used for induction studies and to research metabolism, biochemistry, virology, host/pathogen interactions, and cell biology. Here,...
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...
New FDA Draft Guidance “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics” – XenoTech’s perspective on in vitro DDI testing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The FDA has released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”...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...
Which Hepatocytes Should I Use for What Studies?
- Test Systems & Methods
- March 25, 2022
- Dr. Chris Bohl, Michael Millhollen, Isis Smith
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…
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...
Interesting Topics at the 3rd SCI-RSC Symposium on Transporters in Drug Discovery and Development
- Drug Transporters
- September 22, 2021
- Andy Rhoades, Dr. Andrew G. Taylor, Michael Millhollen, Cody Hendren
A recap of some of the important and promising research that was presented at the Transporters in Drug Discovery and Development symposium...
Why Switch to Hepatocyte Pellets?
- Test Systems & Methods
- June 30, 2021
- Michael Millhollen, Dr. Chris Bohl
You may have heard about the patented CryostaX® format of hepatocyte pellets, but do you know why XenoTech and countless other researchers have made the…
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…
DDI & Drug Repurposing Article featured in Drug Discovery World (DDW) Spring Edition 2021
- Drug Drug Interactions (DDI)
- April 29, 2021
- Madison Esely-Kohlman, Dr. Brian Ogilvie
Repurposing (repositioning, re-profiling, or re-tasking) a drug potentially saves years of costly testing from going to waste and potentially providing a higher chance of success.…
Drug-Drug Interaction (DDI) Prediction Models Following In Vitro Studies in Preclinical Development
- Drug Drug Interactions (DDI)
- August 12, 2020
- Madison Esely-Kohlman, Dr. Pallavi Limaye, Andrea Wolff, Dr. Maciej Czerwinski
In preclinical development, a drug will be evaluated for potential to cause a drug-drug interaction (DDI) using in vitro experiments and then calculations that...
Toxicokinetic (TK) Analysis for Preclinical Drug Development
- In Vivo & Radiolabeling
- August 6, 2020
- Madison Esely-Kohlman, Jolanta Golec, Dr. Pallavi Limaye
The main goal of preclinical toxicokinetic (TK) studies is to establish a correlation between a candidate compound’s concentration or dose...
Important DDI Considerations for Repurposing Drugs to Treat COVID-19
- Drug Drug Interactions (DDI)
- June 8, 2020
- Madison Esely-Kohlman
“Given the rapid spread of COVID-19 and its relatively high mortality, filling the gap for coronavirus-specific drugs is urgent. […]...
Missing Out on Annual ‘Comforting of the Soul’
- Our Team
- May 29, 2020
- Deja Coffin, Madison Esely-Kohlman, Jolanta Golec
As we begin this summer, many of us are grieving opportunities lost for parties and pool days with friends and...
What is ADME and how does it fit into drug development?
- Drug Metabolism
- April 10, 2020
- Madison Esely-Kohlman, Dr. Brian Ogilvie
The main aim of drug development is to get a compound that has a therapeutic effect into the form of...
In Vitro Evaluation of Drug-Drug Interaction (DDI) Potential
- Enzyme Inhibition
- March 24, 2020
- Madison Esely-Kohlman, Zachary Mitts, Dr. Joanna Barbara
In its most recent in vitro drug interaction guidance update, the US Food and Drug Administration (FDA) emphasized harmony with the...
How can in vitro and in vivo studies help me understand my drug’s clearance?
- Regulatory Guidance
- March 5, 2020
- Madison Esely-Kohlman, Dr. Joanna Barbara
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
- Regulatory Guidance
- February 13, 2020
- Madison Esely-Kohlman, Dr. Chris Bohl, Greg Loewen
Beyond the need for evidence that a drug works, Food and Drug Administration (FDA) and other regulatory bodies around the...