Globalization of regulated bioanalysis and the recent advancement of China bioanalysisin regulation

来源 :2015年第一届药代动力学朝阳论坛 | 被引量 : 0次 | 上传用户:wwwdslyj
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  The main purpose of this presentation is to review the recent advancement in regulation and technology with regard to regulated bioanalysis in China and other countries or regions.The presentation contains three major parts.The first part is to discuss the need and current status of globalization of regulated bioanalysis.The second part will focus on comparison of the current guidelines for regulated bioanalysis in EMA, FDA, and Chinese pharmacopoeia.In Europe, the guideline on bioanalytical method validation was published in 2011 and updated in 2014 by EMA.In USA, the current guidance for industry on bioanalytical method validation (BMV) was published in 2001.The new US FDA draft guidance was released in 2013.A follow up report on this draft guidance was published in 2014.In China the first BMV guidance is also implemented in China pharmacopoeia (version 2015).The difference and commonality of these guidances will be discussed.New technology in regulated bioanalysis described in these guidances will be pointed out.The third part is to report the most recent discussion topics from China Bioanalysis Forum.
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