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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The US FDA endorses the use of physiologically based pharmacokinetic (PBPK) models to support formulation and manufacturing changes.
Better Risk Assessment And Dose Determination Key To EMA's Plans For Updated Phase I Trial Guideline
Proposed revisions to the European Medicines Agency's guideline on first-in-human studies are intended to help identify and reduce the risks to study participants by making better use of non-clinical data in areas like the choice of the therapeutic dose, the dose escalation strategy, and the criteria for stopping a trial.
A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.