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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