Cyprotex is a specialist provider of ADME and PK services and provides a range of experimental and bioanalytical services.
Reliable and robust bioanalytical methods are critical in the preclinical development process. Developing a bioanalytical method requires an understanding of structural and physicochemical properties of the test compound in order to optimize the method and identify the most favorable chromatographic methods and sample preparation techniques.
Our advanced bioanalytical method development service is used to demonstrate that a particular bioanalytical method used for quantitative measurement of analytes in a given biological matrix is reliable and reproducible for the intended analytical application.
The fundamental parameters assessed include accuracy and precision, linearity and sensitivity, selectivity, recovery and stability.
Our advanced method development service follows the current FDA Guidance for Industry for Bioanalytical Method Validation published in May 2001, and the current EMA Guideline on Bioanalytical Method Validation which came into effect in Feburary 2012.
For routine screening of compounds, Cyprotex employs a number of generic LC-MS/MS optimization and analysis procedures which guarantee high quality optimization for over 99% of the compounds screened.
Cyprotex also offer a metabolite profiling and identification service. This service provides critical information on the formation of metabolites which is especially important when comparing drug metabolism routes in different species for safety assessment.
|advanced bioanalytical method development|
|metabolite profiling and identification|