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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In October 2017, the FDA released its much-anticipated draft guidance documents for drug-drug interaction (DDI) studies, which was finalized in...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 SEKISUI XenoTech, presented a case study on the importance of the hepatic...

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 discussed critical literature and case studies which have been published since the FDA’s most recent guidance revision issued in...

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

SEKISUI XenoTech is proud to have made contributions to the paper entitled, “Considerations from the IQ Induction Working Group in...

Initial Impressions of New Draft FDA DDI Guidance Documents from SEKISUI XenoTech

Updated Nov. 6th, 2017 The FDA has released its long-awaited new draft guidance for industry on drug-drug interaction (DDI) studies....

Improve the Value of Your Molecule's Testing with Expert Insight

Our expert team of DDI and drug metabolism consultants can help you piece together the data for a successful data package that meets regulatory expectations for thorough risk assessment of a new or repurposed compound

Read our Follow-Up Interview in Outsourcing Pharma

Find the Q&A between Director of Scientific Consulting, Dr. Maciej Czerwinski, and the editorial team at Outsourcing Pharma for more answers about how DDI testing and data interpretation adds value to the drug repurposing process

Human antibodies, including monoclonal and polyclonal, are used for inhibition and immunoblot applications