Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids. Bioanalytical testing involves using a validated bioanalytical method for the quantitative evaluation of analyte(s) in the given biological matrix. This is critical for the successful conduct of nonclinical, biopharmaceutics, and clinical pharmacology studies. It also provides critical data to support the safety and effectiveness of drugs and biological products.
Bioanalytical method development and validation need to comply with FDA, Health Canada, and GLP regulations. Only after the method is successfully validated, should the method be used to analyze the analyte in the validated biological matrix.
In general, validation of a bioanalytical method should include the following parameters:
Any modifications to an already validated bioanalytical method would require partial validation and it can range from as little as one intra-assay accuracy and precision determination to nearly a full validation. Examples of method changes/modifications that would require a partial validation are:
Should you have questions regarding bioanalytical testing or method validation, contact us today.