Leaning on exosomes, model-informed drug development gets closer to tailoring doses to each patient

Model-informed drug development is poised to move into personalized dosing, with a little help from exosomes. An August FDA workshop aims to shed light on when and how to use these precision dosing models in clinical trials and real-world settings.

The workshop is part of FDA’s dual commitments to promote use of model-informed drug development (MIDD) and real-world evidence (RWE) under PDUFA VI (see “Model Alliance”). ...