Format

Send to

Choose Destination
See comment in PubMed Commons below
J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Dec 15;876(2):182-90. doi: 10.1016/j.jchromb.2008.10.040. Epub 2008 Oct 31.

Evaluation of preparative high performance liquid chromatography and cryoprobe-nuclear magnetic resonance spectroscopy for the early quantitative estimation of drug metabolites in human plasma.

Author information

1
Structural ID Group, Toxicokinetics and Biotransformation, PCD DMPK Department, GlaxoSmithKline, Park Road, Ware, Hertfordshire SG12 0DP, UK. gordon.j.dear@gsk.com

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 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.

PMID:
19010088
DOI:
10.1016/j.jchromb.2008.10.040
[Indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Support Center