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wittyboyÖÁ×ðľ³æ (ÖøÃûдÊÖ)
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ÇëÎÊÔÚÉ«Æ×·ÖÎöµÄ·½·¨Ñ§ÆÀ¼ÛÖÐSelectivity ºÍSpecificity Çø±ðÊÇʲô£¿
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лл£¬ ÏÂÃæÊÇÓ¢ÎĽâÊÍ£¬ µ«ÊÇÎÒ»¹ÊÇûŪÇå³þ¾ßÌåÇø±ðÊÇʲô£¬ ÓÈÆäÊÇÔÚÒ©Îï²ÐÁô·½Ãæ The term selectivity is often confused and incorrectly used with the term specificity, especially in the field of chromatographic analytical methods. Selectivity: the selectivity of an assay is a measure of the extent to which the method can determine a parti- cular compound in the analysed matrices without inter- ference from matrix components. A method that is per- fectly selective for an analyte or group of analytes is specific¡£ Specificity: the validation procedure should confirm the ability of the method to unequivocally assess the ana- lyte in the presence of other components that may be present (for example, impurities, degradation products and matrix components). The necessary validation studies depend on the method¡¯s use. Lack of specificity of an individual analytical procedure may be compen- sated by other supporting analytical procedures [2]. This definition from the International Conference on Harmonization (ICH) is restricted to pharmaceuticals, including active substances and formulations. However, in the fields of bioanalysis (analysis of analytes in bio- logical matrices and in bioavailability studies) the spe- cificity is completely neglected. |
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