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Dr. Keith D. Gallicano was invited to present at the Global Bioequivalence Harmonization Initiative (GBHI) 3rd International Conference in Amsterdam on April 12-13, 2018.

May 9, 2018

Dr. Keith D. Gallicano, Novum’s Chief Scientific Officer, was invited to present at the Global Bioequivalence Harmonization Initiative (GBHI) 3rd International Conference in Amsterdam on April 12-13, 2018. Dr. Gallicano presented on the topic “Exclusion of PK Data in BE Assessment: Suggestions for Further Harmonization of Remaining Issues”. Following his presentation, Dr. Gallicano held a discussion with Dr. Wenlei Jiang, Senior Science Advisor, Office of Research and Standards, Office of Generic Drugs of the FDA, on open issues derived from the presentations on exclusion of PK data in BE assessment, presented at the 2nd GBHI conference in Washington D.C. on September 2016.