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Thomas C Hawk

2 papers in the library · publishing 2015-2017

Papers

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Intra‐Target Microdosing – A Novel Drug Development Approach: Proof of Concept, Safety, and Feasibility Study in Humans

Clinical and Translational Science July 8, 2017 T. Burt, D. MacLeod, K. Lee et al.

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...

Intraarterial Microdosing: A Novel Drug Development Approach, Proof-of-Concept PET Study in Rats.

Journal of Nuclear Medicine November 2015 Tal Burt, Douglas C Rouse, Kihak Lee et al.

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...