Document Detail


Metabolite quantitation: detector technology and MIST implications.
MedLine Citation:
PMID:  21083141     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
HPLC detector technology has advanced dramatically over the past 20 years, with a range of highly sensitive and specific detectors becoming available. What is still missing from the bioanalyst's armoury, however, is a highly sensitive detector that gives an equimolar response independent of the compound. This would allow for quantification of compounds without the requirement for a synthetic standard or a radiolabeled analogue. In particular, such a detector applied to metabolism studies would establish the relative significance of the various metabolic routes. The recently issued US FDA guidelines on metabolites in safety testing (MIST) focus on the relative quantitation of human metabolites being obtained as soon as feasible in the drug-development process. In this article, current detector technology is reviewed with respect to its potential for quantitation without authentic standards or a radiolabel and put in the context of the MIST guidelines. The potential for future developments are explored.
Authors:
Pat Wright; Zhuang Miao; Barclay Shilliday
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Bioanalysis     Volume:  1     ISSN:  1757-6199     ISO Abbreviation:  Bioanalysis     Publication Date:  2009 Jul 
Date Detail:
Created Date:  2010-11-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101512484     Medline TA:  Bioanalysis     Country:  England    
Other Details:
Languages:  eng     Pagination:  831-45     Citation Subset:  IM    
Affiliation:
Pfizer Global Research and Development, Sandwich Laboratories, Kent, CT13 9NJ, UK. pat.wright@pfizer.com
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