This episode features Aaron S. Kesselheim of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital discussing the 21st Century Cures Act. Read his commentary in CPT here.
This episode features Lutz Harnisch from Clinical Pharmacology Pharmacometrics at Pfizer, discussing the Drug Disease Model Resources (DDMoRe) consortium. His Perspective article that introduces the activities of the DDMoRe consortium can also be found here.
This episode features Michelle Roth-Cline, Pediatric Ethicist in the Office of Pediatric Therapeutics at the FDA, discussing her Commentary “Microdosing Studies in Children: A US Regulatory Perspective” which published in the September 2016 issue of CPT. Read the commentary here.
In this episode, we interview Dr. Shiew-Mei Huang, Deputy Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research at the Food and Drug Administration about a drug interaction database–a tool for evaluating the impact of renal or hepatic impairment in a pharmacologic inhibition on the systemic exposure of drugs. Read the article here. An Editorial describing the new Database article type can also be found here.