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Publication Detail
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Absolute quantification without internal standards: Accelerator Mass Spectrometry (BioMICADAS) and microtracers for pharmacokinetics, metabolite discovery and mass balance
Publish date: Sep 01, 2009
Author: Stephen Dueker, Pete Lohstroh, Jason Giacomo, Saira Abidi, Dana Pan, Brad Keck and John Vogel
Metabolites can be both mediators of drug toxicity and efficacy and recent
FDA Guidance for Industry strongly recommends that studies leading to in vivo drug metabolism in humans be performed as early as feasible. In this light, a complete accounting of significant metabolite(s) in both safety species and humans during clinical testing is a high priority. The quantitative sensitivity of 14C-Accelerator Mass Spectrometry (AMS) empowers early human metabolism studies to be conducted within Phase I trials with microtrace (nCi) quantities of administered 14C-labled drug. Direct atom counting with AMS can reveal the full complement of metabolites with no requirement for internal standards and
quantifies dose recovery into excreta (mass balance) with a high degree of
reproducibility. These measurements facilitate informed decision-making in and around Phase 1 studies with incremental added cost to the program using trace radiolabel.
Presented at APA Boston 2009.
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