Intra‐Target Microdosing (ITM) is a novel drug development approach aimed at increasing the efficiency of first‐in‐human (FIH) testing of new molecular entities (NMEs). ITM combines intra‐target drug delivery and “microdosing,” the subpharmacological systemic exposure. We hypothesized that when the target tissue is small (about 1/100th of total body mass), ITM can lead to target...
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...