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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 document which describes recommended approaches by which new drug entities should be evaluated for drug-drug interaction potential prior to (or concurrently with) clinical trials and market entry in Japan. Prior to the official translation, SEKISUI XenoTech had been the source for many drug developers for an accurate English translation of the draft guideline. The PMDA made a correction to one legend in the final guideline, and you can read more about the other differences in a recently published letter to Drug Metabolism and Disposition submitted by Dr. Andrew Parkinson. You can hear Drs. Ogilvie and Parkinson further discuss some important differences between requirements prescribed by the FDA, EMA, and PMDA here.

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About the Authors

Madison Knapp received her BS from the University of Missouri – Columbia and became SEKISUI XenoTech’s Scientific Communications Coordinator in 2019 after serving in similar positions at CropLife America, Bond Life Sciences Center and the CAFNR Office of Communications.
Brian Ogilvie currently serves as Vice President of Scientific Consulting at SEKISUI XenoTech. Brian obtained his Ph.D. in toxicology from the University of Kansas Medical Center and B.A. in molecular biology from William Jewell College. He joined XenoTech in 1997. Brian is an author or coauthor on over 50 scientific posters, peer-reviewed publications and book chapters on the topics of drug metabolism, transport and drug-drug interactions, and has represented the company as an invited speaker at various drug metabolism conferences.

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