Coinciding with the Chinese New Year celebrations on Bioanalysis Zone we have a week long focus on bioanalytical work carried out in China. For this event we have worked with Chinese experts from CRO’s and Pharma, to shine light on the regulatory environment in China, the work conducted in Chinese bioanalytical laboratories and how high quality can be ensured in the rapidly growing Chinese Pharma market.
Update on Chinese Regulated Bioanalysis – In this article the China Bioanalytical Forum (CBF) provides an update on the Chinese bioanalytical regulatory landscape, discussing the emergence of recent changes in regulated bioanalysis.
Automation in Chinese bioanalytical CROs for sustained competitiveness and growth – In this commentary the author suggests automation of workflows can help ensure high quality data at Chinese CRO’s, where the turnover of staff is high, and many inexperienced staff carry out bench work.
Highlighted articles from researchers in China
Simultaneous determination of hyzetimibe and its main active metabolite in plasma by LC–MS/MS and its application in PK study – In this article researchers from Zhejiang University School of Medicine, present a simple, highly sensitive LC–MS/MS method for the quantification of hyzetimibe and its main active metabolite, hyzetimibe-glucuronide, in human plasma.
Highly specific and sensitive immunoassay for the measurement of prostaglandin E2 in biological fluids – In this article a team from Peking Union Medical College Hospital and Chengdu University of Traditional Chinese Medicine present a method for producing highly specific anti-PGE2 antibodies, a key challenge in the development of specific immunoassay. Furthermore the team establishes a highly sensitive ELISA, which could be applied to directly analyze PGE2 at pg/ml levels.
Derivatization methods for LC–MS analysis of endogenous compounds – In this review researchers at the Chinese Academy of Sciences cover the derivatization strategies for the LC–MS analysis of various endogenous compounds. The authors also provide applications highlighting the impact of these important techniques in the evaluation of pathological events.
Development of an Excel-based laboratory information management system for improving workflow efficiencies in early ADME screening – In this methodology Xinyan Lu (GlaxoSmithKline R&D, China) details the development of an Excel-based laboratory information management system for improving workflow efficiencies in early ADME screening.
Chinese Bioanalytical forum reports
Society Spotlight: China Bioanalysis Forum – In this article the China Bioanalysis Forum (CBF) is introduced detailing the need for such a organization, the mission and the future plans of CBF.
The 2nd China Bioanalysis Forum Annual Conference: clinical bioanalysis and large molecule bioanalysis – This conference report summarizes the topics covered at the 2nd CBF Annual Conference, which covered the themes of clinical bioanalysis and large molecule bioanalysis.
The 3rd China Bioanalysis Forum annual meeting – This conference report summarizes the major discussion topics at the 3rd CBF Annual Conference. At this conference international speakers attended for the first time also partaking in an open discussion with representatives from Chinese regulatory agencies.