Dried blood spots, pharmacokinetic studies and better medicines for children

Bioanalysis

Volumn 3, Issue 7, 2011, Pages 779-786

  Pandya, Hitesh C ^a   Spooner, Neil ^b   Mulla, Hussain ^c  

^a UNIVERSITY OF LEICESTER   (United Kingdom)

^b GLAXOSMITHKLINE   (United Kingdom)

^c UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; BLOOD SAMPLING; CHILD; COMPARATIVE STUDY; DRIED BLOOD SPOT SAMPLING; DRUG BLOOD LEVEL; DRUG DOSE; DRUG EFFICACY; DRUG SAFETY; HEMATOCRIT; HUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; PLASMA PROTEIN BINDING;

BLOOD SPECIMEN COLLECTION; CHILD; DRUG MONITORING; FEMALE; HUMANS; MALE; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS;

EID: 79953672130     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.11.19     Document Type: Article

References (50)

1. Dezateux C Evaluating newborn screening programmes based on dried blood spots: future challenges. Br. Med. Bull. 54, 877-890 (1998).
2. Déglon J, Thomas A, Cataldo A, Mangin P, Staub C On-line desorption of dried blood spot: a novel approach for the direct LC-MS ana lysis of micro-whole blood samples. J. Pharm. Biomed. Anal. 49, 1034-1039 (2009).
3. Spooner N, Lad R, Barfeld M. Dried blood spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method. Anal. Chem. 81, 1557-1563 (2009).
4. Liang X, Li Y, Barfeld M, Ji QC. Study of dried blood spots technique for the determination of dextromethorphan and its metabolite dextrorphan in human whole blood by LC-MS/MS. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 877, 799-806 (2009).
5. Brindle E, Fujita M, Shofer J, O'Connor KA. Serum, plasma and dried blood spot high-sensitivity C-reactive protein enzyme immunoassay for population research. J. Immunol. Methods 362, 112-120 (2010).
6. Déglon J, Thomas A, Daali Y et al. Automated system for on-line desorption of dried blood spots applied to LC-MS/MS pharmacokinetic study of furbiprofen and its metabolite. J. Pharm. Biomed. Anal. 54, 359-367 (2011).
7. Barfeld M, Spooner N, Lad R, Parry S, Fowles S. Application of dried blood spots combined with HPLC-MS/MS for the quantifcation of acetaminophen in toxicokinetic studies. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 870, 32-37 (2008).
8. Edelbroek PM, van der Heijden J, Stolk LML. Dried blood spot methods in therapeutic drug monitoring: methods, assays and pitfalls. Ther. Drug Monit. 31, 327-336 (2009).
9. Li W, Tse FLS. Dried blood spot sampling in combination with LC-MS/MS for quantitative ana lysis of small molecules. Biomed. Chromatogr. 24, 49-65 (2010).
10. Hill H. Developing trends in bioana lysis. Bioana lysis 1, 1359-1364 (2009).
11. Clark GT, Haynes JJ, Bayliss MAJ, Burrows L. Utilization of DBS within drug discovery: development of a serial microsampling pharmacokinetic study in mice. Bioana lysis 8, 1477-1488 (2010).
12. Patel P, Mulla H, Tanna S, Pandya H. Facilitating pharmacokinetic studies in children: a new use of dried blood spots. Arch. Dis. Child. 95, 484-487 (2010).
13. Chien JY, Ho RJ. Drug delivery trends in clinical trials and translational medicine: evaluation of pharmacokinetic properties in special populations. J. Pharm Sci. 100, 53-58 (2011).
14. Dunne J. The european regulation on medicines for pediatric use. Pediatr. Respir. Rev. 8, 177-183 (2007). (Pubitemid 46888355)
15. Hoppu K. Pediatric clinical pharmacology-at the beginning of a new era. Eur. J. Clin. Pharm. 64, 201-205 (2008).
16. Conroy S, Choonara I, Impicciatore P et al. Survey of unlicensed and off label drug use in pediatric wards in European countries. European Network for Drug Investigation in Children. Br. Med. J. 320, 79-82 (2000). (Pubitemid 30173044)
17. Strauss RG. Anaemia of prematurity: pathophysiology and treatment. Blood Rev. 24, 221-225 (2010).
18. Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin. Pharmacokinet. 47, 231-243 (2008). (Pubitemid 351367434)
19. Hammond J, Chinn S, Richardson H, Rona R. Response to venepuncture for monitoring in primary schools. Arch. Dis. Child. 70, 367-369 (1994).
20. Berrington JE, Snowdon C, Fenton AC Parents' attitudes to neonatal research involving venepuncture. Cli. Ethics 5, 148-155 (2010)
21. EU. Ethical considerations for clinical trials on medicinal products conducted with the pediatric population. Eur J. Health Law 15, 223-250 (2008).
22. Spooner N, Ramakrishnan Y, Barfeld M, Dewit O, Miller S. Use of DBS sample collection to determine circulating drug concentrations in clinical trials: practicalities and considerations. Bioana lysis 2(8), 1515-1522 (2010).
23. Rowland M, Emmons G. Use of dried blood spots in drug development: pharmacokinetic considerations. AAPS J. 12, 290-293 (2010).
24. Emmons GT, Rowland M. Pharmacokinetic considerations as to when to use dried blood spot sampling. Bioana lysis 2(11), 1791-1796 (2010).
25. 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. Bioana lysis 2(8), 1415-1422 (2010).
26. Heinig K, Bucheli F, Hartenbach R, Gajate-Perez A. Determination of mycophenolic acid and its phenyl glucuronide in human plasma, ultrafltrate, blood, DBS and dried plasma spots. Bioana lysis 2(8), 1423-1436 (2010).
27. Bowen CL, Hemberger MD, Kehler JR, Evans CA. Utility of dried blood spot sampling and storage for increased stability of photosensitive compounds. Bioana lysis 2(11), 1823-1828 (2010).
28. Wimpress S, Vara DD, Brightling CE. Improving the sampling technique of arterialized capillary samples to obtain more accurate PaO measurements. Chron. Respir. Dis. 2, 47-50 (2005). (Pubitemid 40193824)
29. Schoeller DA. Changes in total body water with age. Am. J. Clin. Nutr. 50, 1176-1181 (1989). (Pubitemid 19282791)
30. Roggero P, Giannì ML, Amato O, Orsi A, Piemontese P, Morlacchi L, Mosca F. Is term newborn body composition being achieved postnatally in preterm infants? Early Hum. Dev. 85, 349-352 (2009).
31. Roberts KE. Pediatric fuid and electrolyte balance: critical care case studies. Crit. Care Nurs. Clin. North Am. 7, 361-373 (2005). (Pubitemid 41773428)
32. Chiou WL. The phenomenon and rationale of marked dependence of drug concentration on blood sampling site: implications in pharmacokinetics, pharmacodynamics, toxicology and therapeutics (Part 1). Clin. Pharmacokinet. 17, 175-199 (1989). (Pubitemid 19248018)
33. Ehrnebo M, Agurell S, Jalling B, Boreus LO. Age differences in drug binding by plasma proteins: studies on human foetuses, neonates and adults. J. Eur. Clin. Pharmacol. 3, 189-193 (1971).
34. Strolin BM, Baltes EL. Drug metabolism and disposition in children. Fundam. Clin. Pharmacol. 17, 281-299, (2003). (Pubitemid 36774164)
35. Ginsberg G, Hattis D, Sonawane B. Incorporating pharmacokinetic differences between children and adults in assessing children's risks to environmental toxicants. Toxicol. Appl. Pharmacol. 198, 164-183 (2004). (Pubitemid 38952834)
36. Booker PD, Taylor C, Saba G. Perioperative changes in α1-acid glycoprotein concentrations in infants undergoing major surgery. Br J. Anaesth. 76, 365-368 (1996). (Pubitemid 26068826)
37. Bienvenu J, Sann L, Bienvenu F et al. Laser nephelometry of orosomucoid in serum of newborns: reference intervals and relation to bacterial infections. Clin. Chem. 27, 721-726 (1981). (Pubitemid 11065675)
38. Philip AG, Hewitt JR. α1-acid glycoprotein in the neonate with and without infection. Biol. Neonate 43, 118-124 (1983). (Pubitemid 13119960)
39. Wood M, Wood AJ. Changes in plasma drug binding and α1-acid glycoprotein in mother and newborn infant. Clin Pharmacol. Ther. 29, 522-526 (1981). (Pubitemid 11039807)
40. Zlotkin SH, Casselman CW. Percentile estimates of reference values for total protein and albumin in sera of premature infants (less than 37 weeks of gestation) Clin. Chem. 33, 411-413 (1987). (Pubitemid 17161154)
41. Cartlidge PH, Rutter N. Serum albumin concentrations and oedema in the newborn. Arch. Dis. Child 61, 657-660 (1986). (Pubitemid 16070129)
42. Christensen RD, Henry E, Jopling J, Wiedmeier SE. The CBC: reference ranges for neonates. Semin. Perinatol. 33, 3-11 (2000).
43. Will AW. Disorders of iron metabolism: iron defciency, iron overload and the sideroblastic anaemias in Pediatric Haematology. RJ, Hann IM, Smith OP (Eds). Blackwell Publishing, Oxford, UK 79-104 (2006).
44. Pries AR, Secomb TW. Rheology of the microcirculation. Clin. Hemorheol. Microcirc 29, 143-148 (2003). (Pubitemid 38130382)
45. Mei JV, Alexander JR, Adam BW, Hannon WH. Use of flter paper for the collection and ana lysis of human whole blood specimens. J. Nutr. 31, 1631S-1636S (2001). (Pubitemid 32422996)
46. Denniff P, Spooner N. The effect of hematocrit on assay bias when using DBS samples for the quantitative bioana lysis of drugs. Bioana lysis 2, 1385-1395 (2010).
47. Denniff P, Spooner N. Effect of storage conditions on the weight and appearance of dried blood spot samples on various cellulose-based substrates. Bioana lysis 2, 1817-1822 (2010).
48. Benet LZ, Hoener BA. Changes in plasma protein binding have little clinical relevance. Clin. Pharmacol. Ther. 71, 115-121 (2002). (Pubitemid 34271114)
49. Fanta S, Jönsson S, Karlsson MO et al. Long-term changes in cyclosporine pharmacokinetics after renal transplantation in children: evidence for saturable presystemic metabolism and effect of NR1I2 polymorphism. J. Clin. Pharmacol. 50, 581-597 (2010).
50. Beharry M. DBS: a UK (MHRA) regulatory perspective. Bioana lysis 2, 1363-1364 (2010).