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 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.
Hughes
Nicola C
NC
Biovail Contract Research, Toronto, ON M1L 4S4. Nicki.Hughes@biovail.com
Wong
Ernest Y K
EY
Fan
Juan
J
Bajaj
Navgeet
N
D016477:Artifacts; D001331:Automation; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000379:methods*