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| 題 名 | The Validation of Analytical Assays for Biopharmaceutical Studies=生物藥劑學試驗分析方法之認證 |
|---|---|
| 作 者 | 蕭高興; | 書刊名 | 藥物食品分析 |
| 卷 期 | 1:1 1993.01[民82.01] |
| 頁 次 | 頁1-6 |
| 分類號 | 418.6 |
| 關鍵詞 | 分析; 生物; 試驗; 藥劑學; Analytical method; Validation; Quality control; Calibration; |
| 語 文 | 英文(English) |
| 英文摘要 | 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. |
本系統中英文摘要資訊取自各篇刊載內容。