Evaluation of preparative high performance liquid chromatography and cryoprobe-nuclear magnetic resonance spectroscopy for the early quantitative estimation of drug metabolites in human plasma
| Autor: | Andrew D. Roberts, Gordon J. Dear, Stephanie E. North, Claire Beaumont |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Drug
Magnetic Resonance Spectroscopy Chromatography Clinical Trials Phase I as Topic Drug candidate Chemistry Metabolite media_common.quotation_subject Clinical Biochemistry Cell Biology General Medicine Nuclear magnetic resonance spectroscopy Biochemistry High-performance liquid chromatography Analytical Chemistry chemistry.chemical_compound Pharmaceutical Preparations Human plasma Humans Drug Monitoring Quantitative analysis (chemistry) Chromatography High Pressure Liquid Drug metabolism media_common |
| Zdroj: | Journal of Chromatography B. 876:182-190 |
| ISSN: | 1570-0232 |
| Popis: | 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 10 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. |
| Databáze: | OpenAIRE |
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