- 期刊
The Validation of Analytical Assays for Biopharmaceutical Studies
生物藥劑學試驗分析方法之認證
摘要
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、校準線性或非線性、穩定性、回收率、重演性與重覆性）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。
關鍵字
無資料並列摘要
The information required for an adequate analytical method validation for either in vitro or in vivo biopharmaceutical studies is discussed in this article. The most commonly applied assay parameters accuracy, precision, detection limit, 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.
延伸閱讀
- Lin, Y. C. (2010). 平行檢定法於生物製劑學名藥對等性評估之應用 [master's thesis, National Taiwan University]. Airiti Library. https://doi.org/10.6342/NTU.2010.01401
- 許鳳麟、邱進益、林嘉伯（1997）。大陸抗生素製劑鑑別及力價試驗之調查評估。藥物食品檢驗局調查研究年報，()，22-31。https://doi.org/10.6946/ASRNL.199709.0022
- 王榮舫（1975）。生物體實驗室檢驗結果之解釋與應用。工業安全衛生，(14)，4-19。https://www.airitilibrary.com/Article/Detail?DocID=P20160805002-197502-201612010015-201612010015-4-19
- 洪維胤、岳宗漢、林美智、陳玉盆、周秀冠、陳惠芳（2016）。藥品殘留溶劑檢驗方法之建立與開發研究。食品藥物研究年報，(7)，82-95。https://www.airitilibrary.com/Article/Detail?DocID=22195718-201612-201701260015-201701260015-82-95
- 鮑力恒（2010）。國內實施BE臨床試驗情形及其可靠性驗證與藥品品質之探討。臺灣醫界，53(11)，568-571。https://www.airitilibrary.com/Article/Detail?DocID=17263603-201011-201011150085-201011150085-568-571