Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
1216491 | Journal of Chromatography B | 2008 | 9 Pages |
Abstract
Definitive information on the metabolism of a drug candidate in humans is achieved through dosing radiolabelled drug as part of a clinical study, and is typically conducted post-proof of concept in Phase III of the clinical development plan. Here we describe a novel approach, using preparative high performance liquid chromatography and cryoprobe-nuclear magnetic resonance spectroscopy, to determine the human systemic exposure to a drug and its metabolites using samples derived from Phase I clinical studies. Using the described methodology, novel human plasma metabolites, as low as 10Â ng/ml can be detected and quantified. This provides an opportunity, early in the development process to understand the potential role of metabolites in the safety and efficacy of drugs in humans.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
G.J. Dear, A.D. Roberts, C. Beaumont, S.E. North,