Regulatory Guidance
Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents
- Regulatory Guidance
- June 25, 2019
- Madison Esely-Kohlman, Dr. Brian Ogilvie
Dr. Ogilvie’s presentation discusses critical literature and case studies which have been published following the FDA’s 2017 guidance revision, and covered...
Official PMDA English Translation
- Regulatory Guidance
- May 7, 2019
- Madison Esely-Kohlman, Dr. Brian Ogilvie
The Japanese regulatory agent PMDA (Pharmaceuticals and Medical Devices Agency) recently published an official English translation of their final Drug Interaction Guideline...
Important Considerations for the Conduct of In Vitro Drug Transporter Assays
- Drug Transporters
- January 11, 2019
- Greg Loewen, Andrea Wolff, Michael Millhollen
Not only can drug transporters affect the absorption and excretion of drugs, they can be involved in pharmacokinetic-based drug-drug interactions...
FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies
- Regulatory Guidance
- December 6, 2018
- Dr. Brian Ogilvie, Andrea Wolff
In October 2017, the FDA released its much-anticipated draft guidance documents for drug-drug interaction (DDI) studies, which was finalized in...
Coverage from the October 2018 PBSS DDI Workshop
- Drug Transporters
- November 5, 2018
- Greg Loewen, Michael Millhollen
The Pharmaceutical and BioScience Society (PBSS) hosted the workshop “Drug-Drug Interactions: Update on Risk Assessment, Clinical Evaluation and Regulatory Requirements” on October...
October Presentations on In Vitro Effects of Biologics on CYP Enzymes and Regulatory DDI Guidances
- Regulatory Guidance
- October 26, 2018
- Michael Millhollen
On Oct. 15th at the Peptide ADME Discussion Group Workshop in Gothenburg, Sweden, Dr. Brian Ogilvie presented on In vitro Direct and Cytokine-Mediated...
To GLP or not to GLP?
- Regulatory Guidance
- October 5, 2018
- Scott Hickman, Dr. Brian Ogilvie, Tim Patterson
That is the question. . . Knowing the answer may save you time and money Good Laboratory Practices (GLP) are...
Response to FDA Framework for Assessment of Drug-Drug Interactions for Therapeutic Proteins RFI and Comments
- Regulatory Guidance
- August 6, 2018
- Michael Millhollen
In July, Drs. Maciej Czerwinski, Director of Consulting, and Brian Ogilvie, Vice President of Scientific Consulting, submitted XenoTech’s comments in response to the Food...
IQ Induction Working Group Publishes Recommendations for Data Interpretation of In Vitro Induction – Focus on CYP3A4 mRNA
- Enzyme Induction
- July 13, 2018
- Scott Hickman, Dr. Brian Ogilvie
XenoTech is proud to have made contributions to the paper entitled, “Considerations from the IQ Induction Working Group in Response...
New Guidance on Bioanalytical Services
- Regulatory Guidance
- July 6, 2018
- Scott Hickman, Seema Muranjan
XenoTech offers bioanalytical services to support both internal groups and external clients. We have validated LC-MS/MS methods for human CYP markers, UDP...
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