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:

• Reference standards
• Critical reagents
• Calibration curve
• Quality control samples
• Selectivity and specificity
• Sensitivity
• Accuracy
• Precision
• Recovery
• Stability in matrix

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:

• Changes in analytical methodology (e.g., a change in detection systems)
• Changes in sample processing procedures
• Changes in sample volume (e.g., the smaller volume of pediatric samples)
• Changes in instruments and/or software platforms
• Extensions of the assay range
• Changes in the anticoagulant (but no changes in the counter-ion) in harvesting biological fluids (e.g., heparin to EDTA)
• Changes in the matrix within species (e.g., switching from human plasma to human blood) or changes to the species within the matrix (e.g., switching from rat plasma to mouse plasma)
• Changes to the matrices (e.g., cerebrospinal fluid)
• Demonstrating the selectivity of an analyte in the presence of concomitant medications
• Changes in critical reagents (e.g., lot-to-lot changes, changes in reagents)

Should you have questions regarding bioanalytical testing or method validation, contact us today.