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- W2042176003 abstract "Evaluation of selectivity is one of the most controversial aspects of method validation and application of methods to studies. The focus of selectivity testing should address the question: Above what level will interference significantly impact on study conclusions? Four key issues will be addressed: the statistical relevance of any selectivity test performed; a criterion for significant interference; experimental methods to establish selectivity; and criteria for acceptance. To ensure that compound integrity is maintained throughout the work-up process, statistically meaningful methods of stability evaluation which are associated with specific acceptance criteria are required. Suitable methods for evaluating stability of analyte and/or solutions of analyte, in process stability, processed sample stability, long term stability and freeze-thaw stability, as well as meaningful acceptance criteria, are presented." @default.
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- W2042176003 date "1995-12-01" @default.
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- W2042176003 title "Issues in evaluation of bioanalytical method selectivity and drug stability" @default.
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- W2042176003 doi "https://doi.org/10.1016/0731-7085(95)01634-1" @default.
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