May 2019

Induction Junction, What’s Your Function?

Author: Madison Knapp, Rebecca Campbell, Dr. Joanna Barbara Posted: 13 May 2019

Enzyme Induction studies provide insight to a compound’s potential for DDI (drug-drug interaction) and is a required component for an IND submission. Induction potential is informed by testing a compound’s effects on cytochrome P450 (CYP) enzymes representative of three major receptor pathways involved in expression of drug metabolizing enzymes and transporters. In a webinar in April of 2019, Dr. Joanna Barbara addressed frequently asked questions, important study design considerations, and interpretation of study results, discussed here...

Read more

Official PMDA English Translation

Author: Dr. Brian Ogilvie, Madison Knapp Posted: 07 May 2019

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. The PMDA made a correction to one legend in the final guideline. Read more about the differences from the translation of the draft document...

Read more