【求助】Guidance for Industry Bioanalytical Method Validation 有人翻译过吗？

至少俺没有

翻译后记得给大伙分享下啊

楼上很残忍。。。

只翻译过中译英。。。

这个是什么东西？？？

给大家看看行不？

Only the Table of Content

http://www.antpedia.com/?uid-13-action-viewspace-itemid-1523

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