Author(s): Hughes NC, Wong EY, Fan J, Bajaj N
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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.
This article was published in AAPS J
and referenced in Journal of Analytical & Bioanalytical Techniques