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M Rowland

2 papers in the library · 91 citations · publishing 2016

Papers

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Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development

Clinical and Translational Science February 26, 2016 Tal Burt, K Yoshida, Graham Lappin et al. 91 citations

A number of drivers and developments suggest that microdosing and other phase 0 applications will experience increased utilization in the near-to-medium future. Increasing costs of drug development and ethical concerns about the risks of exposing humans and animals to novel chemical entities are important drivers in favor of these approaches, and can be expected only to increase in their...

Microdosing of protein drugs

Clinical Pharmacology & Therapeutics February 1, 2016 M Rowland

Poor pharmacokinetics (PK) can seriously limit clinical utility. Knowing early whether a new compound is likely to have the desired PK profile at therapeutic doses is therefore important. One approach, microdosing,has shown high success with small molecular weight compounds,despite early skepticism. Vlaminget al.report the first, and successful, clinical application of a microdose of a...