Analytical Validation Strategies for Biomarker Assays: A Literature Review BE01-BE05
Dr. Sudheer Moorkoth,
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India.
In recent years biomarker assays have gained precedence both in the clinical and pharmaceutical laboratory. In the pharmaceutical arena biomarkers play multifaceted roles in the safety and efficacy studies of drug development. Alternatively, in the clinical studies, biomarker assays are useful in screening, diagnosis, detection, prognosis and prediction of diseases and disorders. The bio-analytical validation of biomarker assays have been a topic of wide interest. The major bottle neck in this area is the paucity of a fixed regulatory guidance. The various phases in the development of new biomarker assays are pre-analytical considerations, analytical considerations and biomarker assay implementation. The focus of this review is to address in detail the pre-analytical and analytical considerations in the development of new biomarker assays for the pharmaceutical and clinical laboratory. The validation parameters discussed include specificity, sensitivity, matrix effect, precision, accuracy, linearity, dilution linearity, parallelism, carry over, proficiency testing and reference intervals.