Bioanalytical Sciences

Bioanalytical sciences support the measurement and analysis of drugs, metabolites, and biomarkers in biological samples. These data are critical for understanding pharmacokinetics, exposure, and treatment response.

Bioanalytical activities must be designed and executed to meet regulatory expectations for accuracy, precision, and reproducibility. Alignment between bioanalytical methods and clinical study design is essential to ensure data usability.

Reliable bioanalytical data support informed interpretation of clinical and nonclinical results.

Bioanalytical science activities commonly include:

• Bioanalytical strategy and planning

• Method development and validation oversight

• Sample analysis support

• Data review and interpretation

• Alignment with regulatory requirements