Determination of carryover and contamination for mass spectrometry-based chromatographic assays

The Third American Association of Pharmaceutical Scientists/Food and Drug Administration Bioanalytical Workshop, held in 2006, reviewed and evaluated current practices and proposed that carryover and contamination be assessed not only during the validation of an assay but also during the application...

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Bibliographic Details
Published in:The AAPS journal 2007-11, Vol.9 (3), p.E353-E360
Main Authors: Hughes, Nicola C, Wong, Ernest Y K, Fan, Juan, Bajaj, Navgeet
Format: Article
Language:English
Subjects:
Automation
Chromatography, High Pressure Liquid - methods
Reproducibility of Results
Tandem Mass Spectrometry - methods
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Summary:The Third American Association of Pharmaceutical Scientists/Food and Drug Administration Bioanalytical Workshop, held in 2006, reviewed and evaluated current practices and proposed that carryover and contamination be assessed not only during the validation of an assay but also during the application of the method in a study. In this article, the potential risks of carryover and contamination in each stage of a bioanalytical method are discussed, to explain to the industry why this recommendation is being made.
ISSN:1550-7416
1550-7416
DOI:10.1208/aapsj0903042