生物藥劑學試驗分析方法之認證   全文下載

The Validation of Analytical Assays for Biopharmaceutical Studies

本文將討論生物藥劑學體內、體外試驗分析方法論證的必要依據。美國分析方法認證會議曾推薦用分析參數（準確度，精密度，偵測限度，專屬性、選擇性、校準線或非線性、穩定性、回收率、重演性與重複性）作為判斷實驗數據的可採納性。作者將為從事分析方法認證的工作者提供指南，但對專屬分析方法的認證如微生物分析，同位素免疫分析及立體異構體分析未及論述。

The information required for an adequate analytical n1ethod validation for either in vitro or in vivo biopharmaceutical studies is discussed in this article. The most commonly applied assay parameters: accuracy, precision, detection lin1it, specificity, selectivity, calibration linearity or nonlinearity, stability, recovery, reproducibility and repeatability are carefully defined along with some recommendations required for assessing data acceptability arrived at the conference on Analytical Methods Validation. Though more specific analytical issues concerning microbiological assay radioimmunoassay and stereoisomer assay were not examined, this article should provide good guidance to pharmaceutical chemists to properly perform analytical method validation and carry out routine analysis.