FDA发布更新的分析方法验证（草案）

liuzy1974

FDA has updated a 2001 guidance on bioanalytical method validation because of advances in bioanalytical technology and science. Guidance for Industry, Bioanalytical Method Validation, Draft Guidance provides general recommendations for bioanalytical method validation that may be modified depending on the type of method used. The draft offers guidance on the development of bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements.
The guidance applies to gas chromatography (GC); high-pressure liquid chromatography (LC); combined GC and LC mass spectrometric (MS) procedures, such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS; and ligand binding assays (LBAs), and immunological and microbiological procedures that are performed for the quantitative determination of drugs and/or metabolites, and therapeutic proteins in biological matrices, such as blood, serum, plasma, urine, tissue, and skin.

哈尔滨好博

哈哈，沙发，太好了谢谢楼主，下来学习一下

玎玎

线性分析。

liuzy1974

本指南适用于气相色谱（GC）；高压液相色谱（LC）；气相色谱和液相色谱质谱（MS）相结合的程序，如LC-MS，LC-MS-MS，GC-MS，和GC-MS-MS；和配体结合试验（LBA），和免疫和微生物的程序，用于药物、（和/或）代谢物和治疗性蛋白质在生物基质中如血液、血清、血浆、尿液、组织和皮肤中的定量测定。

yuansoul

因为科学技术的发展，所以人家要更新。这不是逼着龙族花钱么。。。。唉。。。。基本的龙族还做不到呢

syhorchid

谢谢分享

胜利者

谢谢分享

沧海.

太好了谢谢楼主，下来学习一下

zengcy38

下载了，谢谢！

LIUHONGXU

下载了，谢谢

仲夏秋夜云

这个值得一看

zwg19710703

哈尔滨好博 发表于 2013-9-16 10:47
哈哈，沙发，太好了谢谢楼主，下来学习一下

谢谢楼主分享

求知者

全英文的，读起来好费力气