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Human-based Systems for Translational Research

1 paper in the library · publishing 2014

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Human Microdosing/Phase 0 Studies to Accelerate Drug Development

Human-based Systems for Translational Research December 9, 2014 R. Colin Garner

Human microdosing Phase 0 studies are used to obtain key information in early drug development concerning a drug's pharmacokinetic and limited pharmacodynamic parameters. Developed as a method in the 2000s, microdosing has become part of the critical path of drug development. Microdosing studies can assist in drug candidate selection prior to going into expensive Phase I studies. This chapter...