Published Online:20 Jun 2018https://doi.org/10.4155/bio-2018-0061
Abstract
Biomarker assays have brought significant challenges to bioanalytical laboratories that historically have provided pharmacokinetic analytical services to the drug development industry. This has largely been due to two reasons: the lack of regulatory guidance in how to validate biomarker assays and the lack of scientists in bioanalytical laboratories with experience in this clinical arena. Since biomarkers have been measured for many decades in clinical laboratories globally, this article reviews the different types of analytical laboratories and their practices and case studies will demonstrate the potential outcomes of using biomarker assays in drug development when they are not validated correctly.
References
- 1 Points to consider document: scientific and regulatory considerations for the analytical validation of assays used in the qualification of biomarkers in biological matrices. Biomarker Assay Collaborative Evidentiary Considerations Writing Group. https://healthpolicy.duke.edu/sites/default/files/atoms/files/cpath_ptc_biomarker_qualification_assays_20170623.pdf (2017).
- 2 BEST (Biomarkers, EndpointS, and other Tools) Resource, FDA-NIH Biomarker Working Group. https://www.ncbi.nlm.nih.gov/books/NBK338448/ (2017).
- 3 US FDA. Guidance for Industry: Bioanalytical Method Validation (2001). https://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf.
- 4 Fit-for-purpose method development and validation for successful biomarker measurement. Pharmaceutical Res. 23(2), (2006).
- 5 et al. Recommendations on biomarker bioanalytical method validation by GCC. Bioanalysis 4(20), 2439–2446 (2012).
- 6 et al. European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug development. Bioanalysis 4(15), 1883–1894 (2012).
- 7 . Biomarker assay validations: a time for change? Drug Dev. Deliv. 17(4), 63–67 (2017).
- 8 Basic Lessons in Laboratory Quality Control, Bio-Rad. http://www.qcnet.com/Portals/0/PDFs/QCWorkbook_Q1109_Jun08.pdf.
- 9 Westgard. Westgard QC Rules and Multirules. https://www.westgard.com/mltirule.htm.
- 10 CLSI, EP19-R: A framework for CLSI Evaluation Protocols (2015). www.clsi.org.
- 11 Clinical and Laboratory Standards Institute. A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures (2nd) Edition. CLSI report EP19 (2015). https://clsi.org/standards/products/method-evaluation/documents/ep19/.
- 12 Document EP5A2: Evaluation of Precision Performance of Clinical Chemistry Devices: Approved Guidelines: 2nd Edition (2011). www.clsi.org.
- 13 Document EP6A: Evaluation of Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline (2011). www.clsi.org.
- 14 Document EP07A2: Interference Testing in Clinical Chemistry: Approved Guideline (2nd Edition) (2005). www.clsi.org.
- 15 Document EP9A2IR: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline (2nd edition). Interim Revision (2011). www.clsi.org.
- 16 Document EP10A3: Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures: Approved Guidelines (3rd edition) (2011). www.clsi.org.
- 17 Document EP24: Evaluation of Matrix Effects: Approved Guideline (3rd edition) (2014). www.clsi.org.
- 18 Document EP15A2: User Demonstration of Performance for Precision and Trueness: Approved Guideline (2nd edition) (2011). www.clsi.org.
- 19 Document EP17A: Protocols for Determination of Limits of Detection and Limits of Quantification: Approved Guideline (2011). www.clsi.org.
