Merck’s perspective on the implementation of dried blood spot technology in clinical drug development – why, when and how

Papers of special note have been highlighted as: ▪▪ of considerable interest

References

• 1  Guthrie R, Susi A. A simple phenylalanine method for detecting phenylketonuria in large populations of newborn infants. Pediatrics32,318–343 (1963).
  Google Scholar
• 2  Wilcken B, Wiley V. Newborn screening. Pathology40(2),104–115 (2008).
  MedlineGoogle Scholar
• 3  Clague A, Thomas A. Neonatal biochemical screening for disease. Clin. Chim. Acta315(1–2),99–110 (2002).
  Medline CASGoogle Scholar
• 4  Cassol SA, Read S, Weniger BG et al. Dried blood spots collected on filter paper: an international resource for the diagnosis and genetic characterization of human immunodeficiency virus type-1. Mem. Inst. Oswaldo Cruz91(3),351–358 (1996).
  Medline CASGoogle Scholar
• 5  Snijdewind IJ, van Kampen JJ, Fraaij PL, van der Ende ME, Osterhaus AD, Gruters RA. Current and future applications of dried blood spots in viral disease management. Antiviral Res.93(3),309–321 (2012).
  Medline CASGoogle Scholar
• 6  Beaudette P, Bateman KP. Discovery stage pharmacokinetics using dried blood spots. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.809(1),153–158 (2004).
  Medline CASGoogle Scholar
• 7  Edelbroek PM, van der Heijden J, Stolk LM. Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther. Drug Monit.31(3),327–336 (2009).
  MedlineGoogle Scholar
• 8  Li W, Tse FL. Dried blood spot sampling in combination with LC–MS/MS for quantitative analysis of small molecules. Biomed. Chromatogr.24(1),49–65 (2010).
  MedlineGoogle Scholar
• 9  Keevil BG. The analysis of dried blood spot samples using liquid chromatography tandem mass spectrometry. Clin. Biochem.44(1),110–118 (2011).
  Medline CASGoogle Scholar
• 10  Patel P, Mulla H, Tanna S, Pandya H. Facilitating pharmacokinetic studies in children: a new use of dried blood spots. Arch. Dis. Child.95(6),484–487 (2010).
  MedlineGoogle Scholar
• 11  Pandya HC, Spooner N, Mulla H. Dried blood spots, pharmacokinetic studies and better medicines for children. Bioanalysis3(7),779–786 (2011).
  CASGoogle Scholar
• 12  Rajendram D, Ayenza R, Holder FM, Moran B, Long T, Shah HN. Long-term storage and safe retrieval of DNA from microorganisms for molecular analysis using FTA matrix cards. J. Microbiol. Methods67(3),582–592 (2006).
  Medline CASGoogle Scholar
• 13  Penezina O, Harvey M. Evaluation of human immunodeficiency virus type I (HIV-1) inactivation by Whatman FTA Elute microcards. Presented at: AIDS 2008 – XVII International AIDS Conference. Mexico City, Mexico, 3–8 August 2008.
  Google Scholar
• 14  Amsterdam P, Waldrop C. The application of dried blood spot sampling in global clinical trials. Bioanalysis2(11),1783–1786 (2010).
  Google Scholar
• 15  Rowland M, Emmons GT. Use of dried blood spots in drug development: pharmacokinetic considerations. AAPS J.12(3),290–293 (2010).
  Medline CASGoogle Scholar
• 16  Emmons G, Rowland M. Pharmacokinetic considerations as to when to use dried blood spot sampling. Bioanalysis2(11),1791–1796 (2010).▪▪ Decision tree for choosing plasma or dried blood spot matrix.
  CASGoogle Scholar
• 17  Pandya HC, Spooner N, Mulla H. Dried blood spots, pharmacokinetic studies and better medicines for children. Bioanalysis3(7),779–786 (2011).
  CASGoogle Scholar
• 18  Denniff P, Spooner N. The effect of hematocrit on assay bias when using DBS samples for the quantitative bioanalysis of drugs. Bioanalysis2(8),1385–1395 (2010). Erratum in: Bioanalysis3(7),818 (2011).
  CASGoogle Scholar
• 19  O’Mara M, Hudson-Curtis B, Olson K, Yueh Y, Dunn J, Spooner N. The effect of hematocrit and punch location on assay bias during quantitative bioanalysis of dried blood spot samples. Bioanalysis3(20),2335–2347 (2011).
  Google Scholar
• 20  Mess JN, Taillon MP, Côté C, Garofolo F. Dried blood spot on-card derivatization: an alternative form of sample handling to overcome the instability of thiorphan in biological matrix. Biomed. Chromatogr.26(12),1617–1624 (2012).
  Medline CASGoogle Scholar
• 21  D’Arienzo CJ, Ji QC, Discenza L et al. DBS sampling can be used to stabilize prodrugs in drug discovery rodent studies without the addition of esterase inhibitors. Bioanalysis2(8),1415–1422 (2010).
  Google Scholar
• 22  Xu Y, Fang W, Zeng W, Leijen S, Woolf EJ. Evaluation of dried blood spot (DBS) technology versus plasma analysis for the determination of MK-1775 by HILIC–MS/MS in support of clinical studies. Anal. Bioanal. Chem.404(10),3037–3048 (2012).
  Medline CASGoogle Scholar
• 23  Meesters R, Hooff G, van Huizen N, Gruters R, Luider T. Impact of internal standard addition on dried blood spot analysis in bioanalytical method development. Bioanalysis3(20),2357–2364 (2011).
  CASGoogle Scholar
• 24  Li F, Ploch S, Fast D, Michael S. Perforated dried blood spot accurate microsampling: the concept and its applications in toxicokinetic sample collection. J. Mass Spectrom.47(5),655–667 (2012).
  Medline CASGoogle Scholar
• 25  Youhnovski N, Bergeron A, Furtado M, Garofolo F. Pre-cut dried blood spot (PCDBS): an alternative to dried blood spot (DBS) technique to overcome hematocrit impact. Rapid Commun. Mass Spectrom.25(19),2951–2958 (2011).
  Medline CASGoogle Scholar
• 26  Fan L, Hall J, Supan E. DMPD (dried matrix on paper disc) – a solution to DBS challenges. CPSA 2012 oral presentation. Presened at: 15th Annual Symposium on Clinical and Pharmaceutical Solutions through Analysis. Langhorne, PA, USA, 1–4 October 2012.
  Google Scholar
• 27  Meesters RJW, Zhang J, van Huizen NA, Hooff GP, Gruters RA, Luider TM. Dried matrix on paper disks: the next generation DBS microsampling technique for managing the hematocrit effect in DBS analysis. Bioanalysis4(16),2027–2035 (2012).
  CASGoogle Scholar
• 28  Viswanathan CT, Bansal S, Booth B et al. Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays. Pharm. Res.24(10),1962–1973 (2007).
  Medline CASGoogle Scholar
• 29  Timmerman P, White S, Globig S, Lüdtke S, Brunet L, Smeraglia J. EBF recommendation on the validation of bioanalytical methods for dried blood spots. Bioanalysis3(14),1567–1575 (2011).
  CASGoogle Scholar
• 30  Spooner N, Lad R, Barfield M. Dried blood spots as a novel sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method. Anal. Chem.81(4),1557–1563 (2009).
  Medline CASGoogle Scholar
• 31  Bowen CL, Dopson W, Kemp DC, Lewis M, Lad R, Overvold C. Investigations into the environmental conditions experienced during ambient sample transport: impact to dried blood spot sample shipments. Bioanalysis3(14),1625–1633 (2011).
  CASGoogle Scholar
• 32  Barfield M, Ahmad S, Busz M. GlaxoSmithKline’s experience of incurred sample reanalysis for dried blood spot samples. Bioanalysis3(9),1025–1030 (2011).
  CASGoogle Scholar
• 101  GE Healthcare Life Sciences. Comparative analysis of FTA™ and NucleoSave™ cards. www.gelifesciences.com/gehcls_images/GELS/Related%20Content/Files/1314807262343/litdoc28982224AA_20110831223354.pdf
  Google Scholar
• 102  Presentation and handling of clinical laboratory data from test tube to table. www.nesug.org/proceedings/nesug07/np/np02.pdf
  Google Scholar
• 103  Blood collection by heel stick (capillary) method – neonates only. www.sphcs.org/workfiles/Laboratory/BloodCollectionbyHeelStickCapillary.pdf
  Google Scholar