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Bioanalysis 

The case study below provides specific example of ways we have helped advance our clients' drug development program in China. A MNC was conducting PK studies in Chinese population for one of their imported drugs. The bioanalytical challenge is they need to detect two endogenous compounds in the serum with LLOQ of 5 pg/mL and 10 pg/mL, respectively in single assay. MicroConstants China offered free feasibility study and within 2 weeks, our method developer, working together with MicroConstants San Diego method development team, came up with a derivatization method that can meet the client's requirement with pure compounds. Then our team developed a method to deplete these two endogenous compounds so that we can have a matrix that can be used for making standards and QC samples. The method was fully validated according to CFDA and EMA guidelines on bioanalytical method validation and successfully used to measure the concentrations of these two endogenous compounds.Since 1998, MicroConstants San Diego has developed over 1,600 LC/MS/MS, HPLC/UV, HPLC/FL, and ELISA methods, including more than 100 non-proprietary assay methods. Our Beijing team work side by side with San Diego team for novel bioanalytical method development for our clients in China. 已验证的生物分析方法列表