The safe and efficient translation of biological insights into human applications is a major public health challenge. Safety concerns are associated with substantial preclinical developmental costs, delaying entry into first-in-human testing. We introduce a novel drug development tool, Intra-Target Microdosing (ITM), combining features of “microdosing,” the systemic subpharmacological testing...
Intraarterial microdosing (IAM) is a novel drug development approach combining intraarterial drug delivery and microdosing. We aimed to demonstrate that IAM leads to target exposure similar to that of systemic full-dose administration but with minimal systemic exposure. IAM could enable the safe, inexpensive, and early study of novel drugs at the first-in-human stage and the study of...