Fig. 4

Key aspects of nonclinical studies of extracellular vesicle (EV) drugs. The key concerns regarding the representativeness of samples, animal species/models, and routes of administration are introduced for developing a nonclinical study strategy for EV-based drugs. The critical aspects of pharmacokinetics, pharmacodynamics, and safety evaluations in nonclinical assessments of EV drugs are outlined. The representative schematics in this figure were created with BioRender.com