ADVANCES IN DRIED BLOOD SPOT SAMPLING AND BIOANALYTICAL METHOD VALIDATION UNDER ICH M10 GUIDELINES: A COMPREHENSIVE REVIEW
DOI:
https://doi.org/10.22159/ijcr.2025v9i4.312Keywords:
Analytical chemistry techniques, Dried blood spot testing, Pharmacokinetics, Clinical trialAbstract
Adaptation of Dried Blood Spot (DBS) as a sample collection technique has gathered significant attention in recent years, which is due to multiple advantages. As this involves a collection of human or animal blood drop and putting them on the specialist paper, this provides multiple benefits like minimal invasive blood sample collection, room temperature or ambient temperature storage till analysis is over. However, all these advantages of DBS do not come easily. Before active application, scientific method development and then method validation as per regulatory requirements is very much required. To ensure achievement of DBS at an optimal level, it is very much essential that the bioanalytical method should be accurate and reproducible. Here International Council for Harmonisation (ICH) M10 guideline plays a pivotal role in supporting a framework for the method validation of methods that will used during regulatory submissions.
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1. Zijp TR, Izzah Z, Aberg C, Gan CT, Bakker SJ, Touw DJ. Clinical value of emerging bioanalytical methods for drug measurements: a scoping review of their applicability for medication adherence and therapeutic drug monitoring. Drugs. 2021;81(17):1983-2002. doi: 10.1007/s40265-021-01618-7, PMID 34724175.
2. Moein MM, Said R, Bassyouni F, Abdel Rehim M. Solid phase microextraction and related techniques for drugs in biological samples. J Anal Methods Chem. 2014 Feb 13;2014:921350. doi: 10.1155/2014/921350, PMID 24688797.
3. Stokes CS, Lammert F, Volmer DA. Analytical methods for quantification of vitamin D and implications for research and clinical practice. Anticancer Res. 2018;38(2):1137-44. doi: 10.21873/anticanres.12332, PMID 29374750.
4. Palnati N, Kotapati N, Vaidyanathan G. Liquid chromatography mass spectrometry/mass spectrometry method for the determination of lapatinib in rat plasma: application to pharmacokinetic studies in Wistar rats. Asian J Pharm Clin Res. 2021;14(2):74-7. doi: 10.22159/ajpcr.2021.v14i2.39660.
5. Permata D, Harahap Y, Ramadon D. Method development and validation of cefoperazone and sulbactam in dried blood spots by high performance liquid chromatography photodiode array detector. Int J App Pharm. 2022;14(5):214-9. doi: 10.22159/ijap.2022v14i5.45078.
6. Sharma A, Jaiswal S, Shukla M, Lal J. Dried blood spots: concepts present status and future perspectives in bioanalysis. Drug Test Anal. 2014;6(5):399-414. doi: 10.1002/dta.1646, PMID 24692095.
7. Michi M, Ferrari L. Validation of a high sensitivity assay for zatebradine in dried blood spots of human blood at pg/ml concentrations using HILIC-MS/MS. Bioanalysis. 2010;2(11):1863-71. doi: 10.4155/bio.10.126, PMID 21083494.
8. Stielow M, Witczynska A, Kubryn N, Fijalkowski L, Nowaczyk J, Nowaczyk A. The bioavailability of drugs the current state of knowledge. Molecules. 2023;28(24):8038. doi: 10.3390/molecules28248038, PMID 38138529.
9. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT. Comparing generic and innovator drugs: a review of 12 y of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583-97. doi: 10.1345/aph.1M141, PMID 19776300.
10. Pandey A, Gupta SP. Personalized medicine: a comprehensive review. Orient J Chem. 2024;40(4):933-44. doi: 10.13005/ojc/400403.
11. Nain M, Sinha A, Sharma A. Dried blood spots: a robust tool for malaria surveillance in countries targeting elimination. J Vector Borne Dis. 2023;60(1):11-7. doi: 10.4103/0972-9062.373616, PMID 37026215.
12. Singh Z. Forensic toxicology: biological sampling and use of different analytical techniques. FRCIJ. 2017;4(4):111-20. doi: 10.15406/frcij.2017.04.00120.
13. Mavragani A, Ochoa G. Infoveillance of infectious diseases in USA: STDs, tuberculosis and hepatitis. J Big Data. 2018;5(1):1-23. doi: 10.1186/s40537-018-0140-9.
14. Dwyer JT, Cunniff PJ, Maroni BJ, Kopple JD, Burrowes JD, Powers SN. The hemodialysis pilot study: nutrition program and participant characteristics at baseline. The hemo study group. J Ren Nutr. 1998;8(1):11-20. doi: 10.1016/s1051-2276(98)90032-2, PMID 9724825.
15. Krum H, Bigger JT, Goldsmith RL, Packer M. Effect of long-term digoxin therapy on autonomic function in patients with chronic heart failure. J Am Coll Cardiol. 1995;25(2):289-94. doi: 10.1016/0735-1097(94)00417-O, PMID 7829779.
16. Desfontaine V, Guillarme D, Francotte E, Novakova L. Supercritical fluid chromatography in pharmaceutical analysis. J Pharm Biomed Anal. 2015;113:56-71. doi: 10.1016/j.jpba.2015.03.007, PMID 25818887.
17. Boso V, Herrero MJ, Bea S, Galiana M, Marrero P, Marques MR. Increased hospital stay and allograft dysfunction in renal transplant recipients with Cyp2c19 AA variant in SNP rs4244285. Drug Metab Dispos. 2013;41(2):480-7. doi: 10.1124/dmd.112.047977, PMID 23175667.
18. McClendon Weary B, Putnick DL, Robinson S, Yeung E. Little to give much to gain what can you do with a dried blood spot? Curr Environ Health Rep. 2020;7(3):211-21. doi: 10.1007/s40572-020-00289-y, PMID 32851603.
19. Magera MJ, Gunawardena ND, Hahn SH, Tortorelli S, Mitchell GA, Goodman SI. Quantitative determination of succinylacetone in dried blood spots for newborn screening of tyrosinemia type I. Mol Genet Metab. 2006;88(1):16-21. doi: 10.1016/j.ymgme.2005.12.005, PMID 16448836.
20. Owens CB, Szalanski AL. Filter paper for preservation storage and distribution of insect and pathogen DNA samples. J Med Entomol. 2005;42(4):709-11. doi: 10.1093/jmedent/42.4.709, PMID 16119565.
21. Barfield M, Spooner N, Lad R, Parry S, Fowles S. Application of dried blood spots combined with HPLC-MS/MS for the quantification of acetaminophen in toxicokinetic studies. J Chromatogr B Analyt Technol Biomed Life Sci. 2008;870(1):32-7. doi: 10.1016/j.jchromb.2008.05.025, PMID 18550454.
22. Abarca R, Gerona R. Development and validation of an LC-MS/MS assay for the quantitative analysis of alprazolam α-hydroxyalprazolam and hydrocodone in dried blood spots. J Chromatogr B Analyt Technol Biomed Life Sci. 2023;1220:123639. doi: 10.1016/j.jchromb.2023.123639, PMID 36906954.
23. Tijare LK, Nt R, Un M. A review on bioanalytical method development and validation. Asian J Pharm Clin Res. 2016;9(9):6-10. doi: 10.22159/ajpcr.2016.v9s3.14321.
24. Ayre AP, Chaudhari PS, Shaikh J, Jagdale S, Agrawal O. Dried matrix spotting an innovative sample preparation tool in bioanalysis. Int J Pharm Sci Res. 2018;9(9):3597. doi: 10.13040/IJPSR.0975-8232.9(9).3597-07.
25. Liu G, Ji QC, Jemal M, Tymiak AA, Arnold ME. Approach to evaluating dried blood spot sample stability during drying process and discovery of a treated card to maintain analyte stability by rapid on card pH modification. Anal Chem. 2011;83(23):9033-8. doi: 10.1021/ac2023876, PMID 21995953.
26. He D, Wang Z, Yang L, Liu T, Yao Y, Mao Z. Modeling and optimization of the drug extraction production process. Scientific Programming. 2016;2016:1-15. doi: 10.1155/2016/3279423.
27. Keith W, John W. Principles and techniques of biochemistry and molecular Biology. 7th ed. Cambridge: Cambridge University Press; 2018.
28. Roskar R, Trdan T. Analytical methods for quantification of drug metabolites in biological samples. In: Calderon L, editor. Chromatography the most versatile method of chemical analysis. In Tech. 2012 Oct 24:440. doi: 10.5772/51676.
29. Bylda C, Thiele R, Kobold U, Volmer DA. Recent advances in sample preparation techniques to overcome difficulties encountered during quantitative analysis of small molecules from biofluids using LC-MS/MS. Analyst. 2014;139(10):2265-76. doi: 10.1039/c4an00094c, PMID 24633191.
30. Shankar EB, Naidu CG, Devaraju S, Rao KV, Ramachandra B, Rao YS. Chiral ionic liquid based vortex assisted enantio separation of s-(+) and r-(–) besifloxacin and evaluation of zeropoint energy by two phase liquid liquid extraction. Orient J Chem. 2024;40(1):194-201. doi: 10.13005/ojc/400124.
31. Sahoo CK, Sudhakar M, Sahoo NK, Ram S, Rao M, Panigrahy UP. Validation of analytical methods: a review. Int J Chromatogr. 2018;01:8. doi: 10.29011/IJCST-112.
32. Khanduri P, Gahtori A. Quantitative UV-spectrophotometric method for the analysis of teneligliptin HBR and metformin HCl in pharmaceutical dosage form: development and validation. Orient J Chem. 2025;40(6):1647-52. doi: 10.13005/ojc/400615.
33. Rahmania TA, Harahap Y, Sandy K. Azithromycin and oseltamivir quantification method developed and validated using liquid chromatography-tandem mass spectrometry in dried blood spot. Int J App Pharm. 2024;16(2):182-7. doi: 10.22159/ijap.2024v16i2.49051.
34. Raju GE, Pottendla S, Yaparthi S. Bioanalytical approach to ensitrelvir estimation using liquid chromatography tandem mass spectrometry and its application to pharmaceutical research. Asian J Pharm Clin Res. 2025;18(3):25-9. doi: 10.22159/ajpcr.2025v18i3.53760.
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