Determination of carryover and contamination for mass spectrometry-based chromatographic assays
Journal Title: The AAPS Journal - Year 2007, Vol 9, Issue 3
Abstract
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.
Authors and Affiliations
Nicola C. Hughes, Ernest Y. K. Wong, Juan Fan, Navgeet Bajaj
Keywords
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- EP ID EP681608
- DOI 10.1208/aapsj0903042
- Views 85
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