ARTICLE | Tools & Techniques
Leaning on exosomes, model-informed drug development gets closer to tailoring doses to each patient
How liquid biopsies could lead to the next big step in modeling dose levels for precision medicine.
May 17, 2019 12:48 AM UTC
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”). ...