Author(s): Elizabeth Mary Mathew, Pragna Rao, Raghavendra Shetty, Leslie Lewis, Sudheer Moorkoth

Email(s): sudheermoorkoth@gmail.com

DOI: 10.5958/0974-360X.2019.00695.4   

Address: Elizabeth Mary Mathew1, Pragna Rao2, Raghavendra Shetty3, Leslie Lewis4, Sudheer Moorkoth1*
1Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104
2Department of Biochemistry, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal-576104
3Ecron Acunova Limited, 4th Floor, Shirdi Saibaba Cancer Hospital, Manipal-576104
4Department of Pediatrics, Kasturba Medical College Manipal, Manipal Academy of Higher Education, Manipal-576104
*Corresponding Author

Published In:   Volume - 12,      Issue - 8,     Year - 2019


ABSTRACT:
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 clinic, biomarker assays are useful in screening, diagnosis, detection, prognosis and prediction of diseases and disorders. The bio analytical validation of biomarker assays has 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 has been to address in detail the pre-analytical and analytical considerations in the development of new biomarker assays in a well-known matrix like dried blood spots both in 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. Additional parameters for dried blood spot assays include hematocrit, blood spot volume, chromatographic effect, spot to spot carry over and DBS vs whole blood/plasma concentration.


Cite this article:
Elizabeth Mary Mathew, Pragna Rao, Raghavendra Shetty, Leslie Lewis, Sudheer Moorkoth. Analytical Validation Strategies for DBS Biomarker Assays. Research J. Pharm. and Tech 2019; 12(8): 4031-4038. doi: 10.5958/0974-360X.2019.00695.4

Cite(Electronic):
Elizabeth Mary Mathew, Pragna Rao, Raghavendra Shetty, Leslie Lewis, Sudheer Moorkoth. Analytical Validation Strategies for DBS Biomarker Assays. Research J. Pharm. and Tech 2019; 12(8): 4031-4038. doi: 10.5958/0974-360X.2019.00695.4   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2019-12-8-85


Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available