Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Editorial

Importance of Method Validation in the Analysis of Biomarker

Author(s): Behrouz Seyfinejad and Abolghasem Jouyban*

Volume 18, Issue 6, 2022

Published on: 05 April, 2022

Page: [567 - 569] Pages: 3

DOI: 10.2174/1573412918666211213142638

[1]
Thompson, M.; Ellison, S.L.R.; Wood, R. Harmonized guidelines for single-laboratory validation of methods of analysis. Pure Appl. Chem., 2002, 74, 835-855.
[http://dx.doi.org/10.1351/pac200274050835]
[2]
Magnusson, B.; Örnemark, U., Eds.; The Fitness For Purpose of Analytical Methods. A Laboratory Guide to Method Validation and Relat-ed Topics, 2nd ed; Eurachem: UK, 2014.
[3]
ICH Validation of Analytical Procedures: Text and Methodology Q2(R1). 2005. Available from: www.ich.org
[4]
Lowes, S.; Ackermann, B.L. AAPS and US FDA Crystal City VI workshop on bioanalytical method validation for biomarkers. Bioanalysis, 2016, 8(3), 163-167.
[http://dx.doi.org/10.4155/bio.15.251] [PMID: 26795584]
[5]
Arnold, M.E.; Booth, B.; King, L.; Ray, C. Workshop report: crystal city VI-bioanalytical method validation for biomarkers. AAPS J., 2016, pp. 1366-1372.
[6]
Azizi, S.; Shahrisa, A.; Khoubnasabjafari, M.; Ansarin, K.; Khoubnasabjafari, M.; Soleymani, J.; Jouyban, A. A possible reason for the low reproducibility of malondialdehyde determinations in biological samples. Bioanalysis, 2016, 8(21), 2179-2181.
[http://dx.doi.org/10.4155/bio-2016-0228] [PMID: 27667475]
[7]
Khoubnasabjafari, M.; Ansarin, K.; Jouyban, A. Reliability of malondialdehyde as a biomarker of oxidative stress in psychological disor-ders. Bioimpacts, 2015, 5(3), 123-127.
[PMID: 26457249]
[8]
Khoubnasabjafari, M.; Jouyban, A. Challenges on determination of malondialdehyde in plant samples. Arch. Crop Sci, 2020, 4(1), 64-66.
[9]
Khoubnasabjafari, M.; Soleymani, J.; Jouyban, A. Avoid using spectrophotometric determination of malondialdehyde as a biomarker of oxidative stress. Biomarkers Med., 2018, 12(6), 551-554.
[http://dx.doi.org/10.2217/bmm-2017-0437] [PMID: 29873547]
[10]
Khoubnasabjafari, M.; Ansarin, K.; Jouyban, A. Critical review of malondialdehyde analysis in biological samples. Curr. Pharm. Anal., 2016, 12(1), 4-17.
[http://dx.doi.org/10.2174/1573412911666150505185343]
[11]
Pussard, E.; Neveux, M.; Guigueno, N. Reference intervals for urinary catecholamines and metabolites from birth to adulthood. Clin. Biochem., 2009, 42(6), 536-539.
[http://dx.doi.org/10.1016/j.clinbiochem.2008.10.022] [PMID: 19027729]
[12]
Barco, S.; Gennai, I.; Reggiardo, G.; Galleni, B.; Barbagallo, L.; Maffia, A.; Viscardi, E.; De Leonardis, F.; Cecinati, V.; Sorrentino, S.; Garaventa, A.; Conte, M.; Cangemi, G. Urinary homovanillic and vanillylmandelic acid in the diagnosis of neuroblastoma: Report from the Italian Cooperative Group for Neuroblastoma. Clin. Biochem., 2014, 47(9), 848-852.
[http://dx.doi.org/10.1016/j.clinbiochem.2014.04.015] [PMID: 24769278]
[13]
Davidson, D.F.; Hammond, P.J.; Murphy, D.; Carachi, R. Age-related medical decision limits for urinary free (unconjugated) metadrena-lines, catecholamines and metabolites in random urine specimens from children. Ann. Clin. Biochem., 2011, 48(Pt 4), 358-366.
[http://dx.doi.org/10.1258/acb.2011.011023] [PMID: 21670092]
[14]
US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry: bioanalytical method validation; Rockville, MD, USA, 2001.
[15]
European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on Bioanalytical Method Validation; London, UK, 2011.
[16]
Clinical and Laboratory Standards Institute (CLSI) guidelines (formerly NCCLS) for Biomarkers. Available from: www.clsi.org
[17]
Hougton, R.; Gouty, D.; Allinson, J.; Green, R.; Losauro, M.; Lowes, S.; LeLacheur, R.; Garofolo, F.; Couerbe, P.; Bronner, S.; Struwe, P.; Schiebl, C.; Sangster, T.; Pattison, C.; Islam, R.; Garofolo, W.; Pawula, M.; Buonarati, M.; Hayes, R.; Cameron, M.; Nicholson, R.; Harman, J.; Wieling, J.; De Boer, T.; Reuschel, S.; Cojocaru, L.; Harter, T.; Malone, M.; Nowatzke, W. Recommendations on biomarker bioanalyti-cal method validation by GCC. Bioanalysis, 2012, 4(20), 2439-2446.
[http://dx.doi.org/10.4155/bio.12.197] [PMID: 23157353]

© 2024 Bentham Science Publishers | Privacy Policy