EMA To Beef Up Use Of PBPK Models In Drug Development And Evaluation
New EU guideline will describe how drug developers should go about using physiologically-based pharmacokinetic (PBPK) modeling tools to help predict drug interactions, establish dosing in pediatric or Phase I trials, and other regulatory functions.
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Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.