TSQ增强的可重复性优势体现：大鼠血浆中帕罗西汀生物分析

　　In May 2001, the FDA promulgated its first official guidance for bioanalytical methods.1 This document is titled Guidance for Industry Bioanalytical Method Validation, and serves as a guide for bioanalytical methods supporting clinical and non-clinical studies. Recently, the reproducibility and accuracy of the concentration determined in incurred samples was subject of significant debate, outlined in the American Association of Pharmaceutical Scientists (AAPS) journal paper titled Workshop/Conference Report – Quantitative Bioanalytical Methods Validation and Implementation: Best Practice for Chromatographic and Ligand Binding Assays.2 Recommendations were put forth to randomly re-assay a subset of previously assayed incurred samples and compare them to the original value to ensure reproducibility and accuracy. Significant deviation (>15-20%) from the original measurement would then require re-evaluation of the bioanalytical method.