Author: Dr. Brian Ogilvie
FDA Guidance: Many In Vitro DDI Evaluations Should Precede FIH Studies
In October 2017, the FDA released its much-anticipated draft guidance documents for drug-drug interaction (DDI) studies, which was finalized in...
New Recommendation: Evaluate NMEs for OCT1 Transporter-Mediated DDI Potential
Brian Ogilvie, Ph.D., Vice President of Scientific Consulting at XenoTech, presented a case study on the importance of the hepatic OCT1...
New FDA Draft Guidance “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics” – XenoTech’s perspective on in vitro DDI testing
The FDA has released a new draft guidance for industry titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.”...
DDI & Drug Repurposing Article featured in Drug Discovery World (DDW) Spring Edition 2021
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.…
What is ADME and how does it fit into drug development?
The main aim of drug development is to get a compound that has a therapeutic effect into the form of...
Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents
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
The Japanese regulatory agent PMDA (Pharmaceuticals and Medical Devices Agency) recently published an official English translation of their final Drug Interaction Guideline...
To GLP or not to GLP?
That is the question. . . Knowing the answer may save you time and money Good Laboratory Practices (GLP) are...
IQ Induction Working Group Publishes Recommendations for Data Interpretation of In Vitro Induction – Focus on CYP3A4 mRNA
XenoTech is proud to have made contributions to the paper entitled, “Considerations from the IQ Induction Working Group in Response...
Initial Impressions of New Draft FDA DDI Guidance Documents from XenoTech
Updated Nov. 6th, 2017 The FDA has released its long-awaited new draft guidance for industry on drug-drug interaction (DDI) studies....
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