microconstants > ourservices > PK Analysis > Bioanalytical Method Development and Validation

Bioanalytical Method Development and Validation

2017-02-21 16:18:17
Our method development team in specializes in developing robust methods for the analysis of small molecules, proteins, peptides, and metabolites. 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. 
 
We have solved difficult analytical problems including the detection of amino acids, peptides, steroids, cephalosporins, and chiral separation of various enantiomers using liquid chromatography/tandem mass spectrometry (LC/MS/MS). Despite the analytical complexity, our scientists approach every compound with creativity, innovation, and years of scientific knowledge, allowing us to uncover solutions to complex bioanalytical challenges.  
 
MicroConstants performs method validations, method transfers, partial validations, cross-matrix validations, full GLP validations, or any combination of them required to meet your analytical needs. 
 
All GLP methods are validated in accordance with the USFDA Guidance for Industry, Bioanalytical Method Validation, European Medicines Agency (EMA) and CFDA Guidelines on Bioanalytical Method Validation. And the validation is performed in accordance with USFDA, OECD, MHLW and CFDA Good Laboratory Practice regulations. 
 
Typically, during bioanalytical method validations, we evaluate the following parameters: 
Intraday accuracy and precision (high, medium, low and LLOQ QC) 
Intraday accuracy and precision (high, medium, low and LLOQ QC) 
Specificity 
Matrix effect 
Carry over 
Recovery 
Dilution integrity 
Standard solution stability (bench-top and long term storage) 
Sample stability (short-term thawed sample, long-term sample storage, freeze/thaw sample, processed sample) 
Reinjection integrity 
Incurred sample reproducibility (ISR) 
Hemolysis effect 
Lipemic effect 
Whole blood stability 
Non-interference 
Batch size determination