Guidance for Industry Bioanalytical Method Validation
I. 简介.............................................................................................1 II. 背景............................................................................................1 A. 全认证........................................................................................2 B.部分认证.................................................................................... 2 C. 交叉认证 ..................................................................................3 III. 参考标准....................................................................................4 IV.方法开发：化学方面的.............................................................4 A. 灵敏度.........................................................................................4 B. 准确度，精密度和重现性.........................................................5 C.校正/标准曲线 ...........................................................................5 D. 稳定性..........................................................................................6 E. 建立和认证生物分析方法的原则..............................................8 F. 方法认证的特别推荐................................................................10 V. 方法开发：：微生物和配合物................................................11 A. 选择性........................................................................................11 B. 定量............................................................................................12 VI. 常规药物分析的认证的应用...................................................13 运行样品的接受准则.....................................................................15 VII. 文档（Documentation））.....................................................16 A. 总结...........................................................................................16 B. 方法建立的文档........................................................................17 C. 常规药物分析的应用...............................................................17 D. 其它信息...................................................................................19 词汇速查.......................................................................................20
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