PBPK Modeling and Simulation: Yesterday’s Scientific Endeavor is Today’s Regulatory Necessity
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Tag: EMA
The European Regulatory Landscape for Pediatric Drug Development
In my 35 years of working to develop safer, more effective medications for children, I’ve often been asked about how to navigate the regulatory landscape in the US and Europe. In a previous blog post, I discussed the latest FDA trends regarding pediatric drug development. In this blog, I’ll focus on the path for achieving […]
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Clinical Pharmacology Strategy, PK/PD Modeling & Simulation