基于质谱的色谱分析中残留和污染的测定。
Determination of carryover and contamination for mass spectrometry-based chromatographic assays.
作者信息
Hughes Nicola C, Wong Ernest Y K, Fan Juan, Bajaj Navgeet
机构信息
Biovail Contract Research, Toronto, ON M1L 4S4.
出版信息
AAPS J. 2007 Nov 2;9(3):E353-60. doi: 10.1208/aapsj0903042.
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.
摘要
2006年举办的第三届美国药物科学家协会/食品药品监督管理局生物分析研讨会，对当前的做法进行了审查和评估，并建议不仅在分析方法验证期间，而且在研究中该方法的应用过程中，都要评估残留和污染情况。在本文中，将讨论生物分析方法各个阶段中残留和污染的潜在风险，以便向业界解释提出这一建议的原因。
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