Bioanalysis

Cyprotex is a specialist provider of ADME and PK services and provides a range of experimental and bioanalytical services.

Bioanalytical method development and validation

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 optimise the method and identify the most favourable chromatographic methods and sample preparation techniques.

Bioanalytical method validation 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 for validation include accuracy and precision, linearity and sensitivity, selectivity, recovery and stability.

Cyprotex offer a comprehensive bioanalytical method development and validation service. Our validation service follows the current FDA Guidance for Industry for Bioanalytical Method Validation published in May 2001.

Bioanalytical screening methods

For routine screening of compounds, Cyprotex employs a number of generic LC-MS/MS optimisation and analysis procedures which guarantee high quality optimisation for over 99% of the compounds screened.

Metabolite profiling and identification

Under Cloe Select, 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.