Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group

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• 作者：Christopher Evans (1)
  Mark Arnold (2)
  Peter Bryan (3)
  Jeffrey Duggan (4)
  Christopher A James (5)
  Wenkui Li (6)
  Steve Lowes (7)
  Luca Matassa (8)
  Timothy Olah (9)
  Philip Timmerman (10)
  Xiaomin Wang (11)
  Enaksha Wickremsinhe (12)
  John Williams (13)
  Eric Woolf (14)
  Patricia Zane (15)
  
  1. Bioanalytical Science and Toxicokinetics (BST) ; PTS-DMPK ; GlaxoSmithKline ; 709 Swedeland Road ; King of Prussia ; PA ; 19406 ; USA
  2. Bioanalytical Sciences and Selective Integration ; Bristol-Myers Squibb ; Princeton ; NJ ; 08543 ; USA
  3. B2S Consulting ; Mendham ; NJ ; 07945 ; USA
  4. Bioanalysis and Metabolite Profiling ; Boehringer-Ingelheim Pharmaceuticals Inc. ; Ridgefield ; CT ; 06877 ; USA
  5. Bioanalytical Sciences ; PKDM ; Amgen ; Thousand Oaks ; CA ; 91320 ; USA
  6. DMPK/Early Bioanalytics & Technology (EBT) ; Novartis Institutes for BioMedical Research ; East Hanover ; NJ ; 07936 ; USA
  7. Bioanalytical and ADME Labs ; Quintiles ; Ithaca ; NY ; 14850 ; USA
  8. Bioanalytical QPS ; LLC ; Newark ; DE ; USA
  9. Bioanalytical Research ; Bristol-Myers Squibb ; Princeton ; NJ ; USA
  10. Janssen Research & Development ; Beerse ; Belgium ; 2340
  11. Bioanalysis ; DMPK ; Celgene Corporation ; Summit ; NJ ; 07901 ; USA
  12. Lilly Research Laboratories ; Eli Lilly and Company ; Indianapolis ; IN ; 46285 ; USA
  13. Drug Metabolism and Pharmacokinetics ; Vertex Pharmaceuticals Inc. ; Boston ; MA ; 02210 ; USA
  14. PPDM Global Bioanalytics ; Merck and Company ; West Point ; PA ; 19486 ; USA
  15. Drug Disposition ; Safety ; and Animal Research (DSAR) ; Sanofi U.S. ; Bridgewater ; NJ ; 08807 ; USA
  
• 刊名：The AAPS Journal
• 出版年：2015
• 出版时间：March 2015
• 年：2015
• 卷：17
• 期：2
• 页码：292-300
• 全文大小：418 KB
• 参考文献：1. Rahavendran, SV, Vekich, S, Skor, H, Batugo, M, Nguyen, L, Shetty, B (2012) Discovery pharmacokinetic studies in mice using serial microsampling, dried blood spots and microbore LC-MS/MS. Bioanalysis 4: pp. 1077-95 CrossRef
  2. Beaudette, P, Bateman, KP (2004) Discovery stage pharmacokinetics using dried blood spots. J Chromatogr B Anal Technol Biomed Life Sci 809: pp. 153-8 CrossRef
  3. Barfield, M, Spooner, N, Lad, R, Parry, S, Fowles, S (2008) Application of dried blood spots combined with HPLC-MS/MS for the quantification of acetaminophen in toxicokinetic studies. J Chromatogr B 870: pp. 32-37 CrossRef
  4. Spooner, N, Ramakrishnan, Y, Barfield, M, Dewit, O, Miller, S (2010) Use of DBS sample collection to determine circulating drug concentrations in clinical trials: practicalities and considerations. Bioanalysis 2: pp. 1515-1522 CrossRef
  5. http://www.cdc.gov/labstandards/pdf/vitaleqa/Poster_PreparingDBS.pdf
  6. D鈥橝rienzo, C, Ji, Q, Discenza, L, Cornelius, G, Hynes, J, Cornelius, L (2010) DBS sampling can be used to stabilize prodrugs in drug discovery rodent studies without the addition of esterase inhibitors. Bioanalysis 2: pp. 1415-1422 CrossRef
  7. Bowen, CL, Volpatti, J, Cades, X, Licea-Perez, H, Evans, CA (2012) Evaluation of glucuronide metabolite stability in dried blood spots. Bioanalysis 4: pp. 2823-2832 CrossRef
  8. Personal communications from authors Pat Zane and Chris James
  9. Liu, G, Ji, QC, Jemal, M, Tymiak, AA, Arnold, ME (2011) 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 83: pp. 9033-9038 CrossRef
  10. Guthrie, R, Susi, A (1963) A simple phenylalanine method for detecting phenylketonuria in large populations of newborn infants. Pediatrics 32: pp. 338-343
  11. Edelbroek, PM, Heijden, J, Stolk, LM (2009) Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther Drug Monit 31: pp. 327-336 CrossRef
  12. Solomon, SS, Solomon, S, Rodriguez, II, McGarvey, ST, Ganesh, AK, Thyagarajan, SP (2002) Dried blood spots (DBS): a valuable tool for HIV surveillance in developing/tropical countries. Int J STD AIDS 13: pp. 25-28 CrossRef
  13. Dainty, TC, Richmond, ES, Davies, I, Blackwell, MP (2012) Dried blood spot bioanalysis: an evaluation of techniques and opportunities for reduction and refinement in mouse and juvenile rat toxicokinetic studies. Int J Toxicol 31: pp. 4-13 CrossRef
  14. Festing, S, Wilkinson, R (2007) The ethics of animal research. Eur Mol Biol Organ Rep 8: pp. 526-530
  15. Dainty, TC, Richmond, ES, Davies, I, Blackwell, MP (2012) Dried blood spot bioanalysis: an evaluation of techniques and opportunities for reduction and refinement in mouse and juvenile rat toxicokinetic studies. Int J Toxicol 31: pp. 4-13 CrossRef
  16. Zisowsky, J, Krause, A, Dingemanse, J (2010) Drug development for pediatric populations: regulatory aspects. Pharm 2: pp. 364-388
  17. Beharry, M (2012) DBS: a UK (MHRA) regulatory perspective. Bioanalysis 2: pp. 1363-1364 CrossRef
  18. Viswanathan, CT (2012) Perspectives on microsampling: DBS. Bioanalysis 4: pp. 1417-1419 CrossRef
  19. Viswanathan CT. Regulatory Perspectives on Dried Blood Spots. 12th Annual Land O鈥橪akes Bioanalytical Conference; Agency and Industry Perspectives on Biomarkers, Bloodspots and Beyond, Merrimac, WI, July 2011.
  20. Timmerman P, White S, Cobb Z, de Vries R, Thomas E, van Baar B. Update of the EBF recommendation for the use of DBS in regulated bioanalysis integrating the conclusions from the EBF DBS-microsampling consortium. 2013; 5(17): 2129鈥?136.
  21. Abbott R, Smeraglia J, White S, Luedtke S, Brunet L, Thomas E, Globig S, and Timmerman P. Conference Report: Connecting strategies on dried blood spots. 2010; Bioanalysis: 2 (11) 1809鈥?816
  22. Evans, CA, Bruce, C, Emmons, GT, Gallenberg, L, Ji, QC, Kinter, L (2010) DIA/PhRMA workshop on dried blood spot sampling in the pharmaceutical industry: methodology, implementation and best practices. Bioanalysis 2: pp. 1355-1359 CrossRef
  23. Kehler, JR, Bowen, CL, Boram, SL, Evans, CA (2010) Application of DBS for quantitative assessment of the peptide Exendin-4; comparison of plasma and DBS method by UHPLC-MS/MS. Bioanalysis 2: pp. 1461-1468 CrossRef
  24. Li, W, Tse, FL (2010) Dried blood spot sampling in combination with LC-MS/MS for quantitative analysis of small molecules. Biomed Chromatogr 24: pp. 49-65 CrossRef
  25. Zane P, Emmons G. Microsampling in Pharmaceutical Bioanalysis. Online eBook Chapter. Future Science; 2013.
  26. O鈥橫ara, M, Hudson-Curtis, B, Olson, K, Yueh, Y, Dunn, J, Spooner, N (2011) The effect of hematocrit and punch location on assay bias during quantitative bioanalysis of dried blood spot samples. Bioanalysis 3: pp. 2335-2347 CrossRef
  27. Denniff, P, Spooner, N (2010) The effect of hematocrit on assay bias when using DBS samples for the quantitative analysis of drugs. Bioanalysis 2: pp. 1385-1395 CrossRef
  28. Vries, R, Barfield, M, Merbel, N, Schmid, B, Siethoff, C, Ortiz, J (2013) The effect of hematocrit on bioanalysis of DBS: results from the EBF DBS-microsampling consortium. Bioanalysis 5: pp. 2147-2160 CrossRef
  29. Fan, LM, Lee, JA (2012) Managing the effect of hematocrit on DBS analysis in a regulated environment. Bioanalysis 4: pp. 345-347 CrossRef
  30. Meesters, RJW, Zhang, J, Huizen, NA, Hooff, GP, Gruters, RA, Luider, TM (2012) Dried matrix on paper disks: the next generation DBS microsampling technique for managing the hematocrit effect in DBS analysis. Bioanalysis 4: pp. 2027-2035 CrossRef
  31. Li, FM, Zulkoski, J, Fast, D, Michael, S (2011) Perforated dried blood spots: a novel format for accurate microsampling. Bioanalysis 3: pp. 2321-2333 CrossRef
  32. Xu, Y, Woolf, E, Agrawal, NGB, Kothare, P, Pucci, V, Bateman, KP (2013) Merck鈥檚 perspective on the implementation of dried blood spot technology in clinical drug development鈥攚hat, when and how. Bioanalysis 5: pp. 341-350 CrossRef
  33. Emmons, G, Rowland, M (2010) Pharmacokinetic considerations as to when to use dried blood spot sampling. Bioanalysis 2: pp. 1791-1796 CrossRef
  34. Emmons, G, Rowland, M (2010) Use of dried blood spots in drug development: pharmacokinetic considerations. AAPS J 12: pp. 290-293 CrossRef
  35. Wickremsinhe, ER, Huang, NH, Abdul, BG, Knott, K, Ruterbories, KJ, Manro, JR (2013) Preclinical bridging studies: understanding dried blood spot and plasma exposure profiles. Bioanalysis 5: pp. 159-170 CrossRef
  36. Chiou, WL (1989) The phenomenon and rationale of marked dependence of drug concentration on blood sampling site. Implications in pharmacokinetics, pharmacodynamics, toxicology and therapeutics. Clin Pharmacokinet 17: pp. 175-199 CrossRef
  37. Timmerman, P (2014) Tiered approach revisited: introducing stage-appropriate or assay-appropriate scientific validation. Bioanalysis 6: pp. 599-604 CrossRef
  38. Denniff, P, Spooner, N (2014) Volumetric absorptive microsampling: a dried sample collection technique for quantitative bioanalysis. Anal Chem 86: pp. 8489-95 CrossRef
  39. Chapman C, Chivers S, Gliddon D, Mitchell D, Robinson S, Sangster T, Sparrow S, Spooner N, Wilson A. Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies. Drug Discovery Today. 2014 (in press)
  40. Kim, JH, Woenker, T, Adamec, J, Regnier, FE (2013) Simple, miniaturized blood plasma extraction method. Anal Chem 85: pp. 11501-11508 CrossRef
  
• 刊物主题：Pharmacology/Toxicology; Biochemistry, general; Biotechnology; Pharmacy;
• 出版者：Springer US
• ISSN：1550-7416

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