Chatting with Mayumi Hasegawa: Global Drug Development Expert
Dr. Mayumi Hasegawa is a clinical pharmacology and pharmacometrics expert who specializes in drug development for the Asia-Pacific regions.
Month: October 2019
New FDA Initiatives: Project Orbis and Real-Time Oncology Review
The U.S. Food and Drug Administration (FDA) recently announced two exciting and innovative initiatives from FDA’s Oncology Center of Excellence: Project Orbis and Real-Time Oncology Review (RTOR) Pilot Program. Project Orbis Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), will provide a framework for concurrent submission and review of oncology products between international … Continued
ICER’s Unsupported Drug Price Increase Report: An Analysis
We analyze the drug-price watchdog, ICER’s (Institute for Clinical and Economic Review) “Report on Unsupported Price Increases.”
Development of a PBPK model for the prediction of Amiodarone pharmacokinetics in fed and fasted state using the Advanced Dissolution, Absorption and Metabolism (ADAM) model
Certara Will Contribute to 26 Model-Informed Drug Development Sessions at ACoP10
Oct 18, 2019 Sessions feature physiologically-based pharmacokinetic (PBPK), pharmacokinetic/pharmacodynamic (PK/PD) and quantitative systems pharmacology (QSP) modeling and simulation