Biological assays require that the drug be detected in biological matrices such as serum, plasma, whole blood, urine or various tissues.

Typical method development parameters that should be investigated include the determination of specificity / selectivity, the generation of a calibration curve in the appropriate matrix that allows an estimation of the analytical range and the selection of the appropriate statistical evaluation approach. An appropriate bioanalytical method is required to detect drug at these low levels, as well as linearly over an appropriate range. Matrix effects and stability issues can also make accurate analysis of the analyte difficult; these include, among many others, endogenous materials extracted from the biological matrix that may interfere in the analysis, enzymes in the biological fluid that are capable of metabolizing the analyte, plasma proteins that the analyte can bind to, and concomitant drugs that might interfere in the analysis. All these factors must be considered when planning an analysis.

Vela's many years of assay development have led to a level of expertise in these complex matrices that enable the success of your assay development.