299
Views
6
CrossRef citations to date
0
Altmetric
Reviews

Methods for pharmacokinetic analysis in young children

&

Bibliography

  • Choonara I. Unlicensed and off-label drug use in children: implications for safety. Expert Opin Drug Saf 2004;3(2):81-3
  • Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr 2005;164:552-8
  • Shah SS, Hall M, Goodman DM, et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med 2007;161(3):282-90
  • Pasquali SK, Hall M, Slonim AD, et al. Off-label use of cardiovascular medications in children hospitalized with congenital and acquired heart disease. Circ Cardiovasc Qual Outcomes 2008;1:74-83
  • Hsu B, Brazelton T. Off-label medication use in an academic hospital pediatric critical care unit. WMJ 2009;108(7):343-8
  • Bazzano AT, Mangione-Smith R, Schonlau M, et al. Off-label prescribing to children in the United States outpatient setting. Acad Pediatr 2009;9(2):81-8
  • Tobin JR. Pediatric drug labeling: still an unfinished need. Anesth Analg 2012;115(5):987-8
  • Smith MC, Williamson J, Yaster M, et al. Off-label use of medications in children undergoing sedation and anesthesia. Anesth Analg 2012;115(5):1148-54
  • Ballard CDJ, Peterson GM, Thompson AJ, Beggs SA. Off-label use of medicines in paediatric inpatients at an Australian teaching hospital. J Paediatr Child Health 2013;49(1):38-42
  • Zuppa A, Adamson PC, Mondick JT, et al. Drug utilization in the pediatric intensive care unit: monitoring prescribing trends and establishing prioritization of pharmacotherapeutic evaluation of critically ill children. J Clin Pharmacol 2005;45(11):1305-12
  • Food and Drug Administration Safety and Innovation Act of 2012. Public Law no. 112-144, 126 STAT 993. 2012. Available from: http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf [Last accessed 5 September 2013]
  • Best Pharmaceuticals for Children Act of 2002. Public Law no. 107-109, 115 STAT 1408. 2002. Available from: http://www.gpo.gov/fdsys/pkg/PLAW-107publ109/pdf/PLAW-107publ109.pdf [Last accessed 5 September 2013]
  • Pediatric Research Equity Act of 2003. Public Law no. 108-155, 117 STAT 1936. 2003. Available from: http://www.gpo.gov/fdsys/pkg/STATUTE-117/pdf/STATUTE-117-Pg1936.pdf [Last accessed 5 September 2013]
  • European Parliament and Council of the European Union. Regulation (EC) No. 1901/2006 on medicinal products for pediatric use. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:378:0001:0019:EN:PDF [Last accessed 10 November 2013]
  • Benjamin DK Jr, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 2006;296(10):1266-73
  • Rodriguez W, Selen A, Avant D, et al. Improving pediatric dosing through pediatric initiatives: what we have learned. Pediatrics 2008;121(3):530-9
  • Benjamin DK Jr, Smith PB, Sun JM, et al. Safety and transparency of pediatric drug trials. Arch Pediatr Adolesc Med 2009;163(12):1080-6
  • Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology – drug disposition, action, and therapy in infants and children. N Engl J Med 2003;349(12):1157-67
  • Anderson GD, Lynn AM. Optimizing pediatric dosing: a developmental pharmacologic approach. Pharmacotherapy 2009;29(6):680-90
  • Anderson BJ. My child is unique; the pharmacokinetics are universal. Paediatr Anaesth 2012;22(6):530-8
  • Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modeling. Clin Pharmacokinet 2008;47(4):231-43
  • Hawcutt DB, Thompson B, Smyth RL, Pirmohamed M. Pediatric pharmacogenomics: an overview. Arch Dis Child 2013;98(3):232-7
  • Neville KA, Becker ML, Goldman JL, Kearns GL. Developmental pharmacogenomics. Paediatr Anaesth 2011;21(3):255-65
  • Sammons H. Ethical issues of clinical trials in children: a European perspective. Arch Dis Child 2009;94(6):474-7
  • Laughon MM, Benjamin DK Jr, Capparelli EV, et al. Innovative clinical trial design for pediatric therapeutics. Expert Rev Clin Pharmacol 2011;4(5):643-52
  • Shaddy RE, Denne SC; for The Committee on Drugs and Committee on Pediatric Research. Clinical report - guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 2010;125(4):850-60
  • Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharamcokinet 2010;49(8):493-507
  • Yanni S. Disposition and interaction of biotherapeutics in pediatric populations. Curr Drug Metab 2012;13(7):882-900
  • Xu Z, Davis HM, Zhou H. Rational development and utilization of antibody-based therapeutic proteins in pediatrics. Pharmacol Ther 2013;137(2):225-47
  • Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric Population. Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to the good clinical practice in the conduct of clinical trials on medicinal products for human use. Available from: http://ec.europa.eu/health/files/eudralex/vol-10/ethical_considerations_en.pdf [Last accessed 10 November 2013]
  • Musteata FM. Pharmacokinetic applications of microdevices and microsampling techniques. Bioanalysis 2009;1(1):171-85
  • Cohen-Wolkowiez M, Ouellet D, Smith PB, et al. Population pharmacokinetics of metronidazole evaluated using scavenged samples from preterm infants. Antimicrob Agents Chemother 2012;56(4):1828-37
  • Chamberlain JM, Capparelli EV, Brown KM, et al. Pharmacokinetics of intravenous lorazepam in pediatric patients with and without status epilepticus. J Pediatr 2012;160(4):667-72
  • Garcia B, Barcia E, Perez F, et al. Population pharmacokinetics of gentamicin in premature newborns. J Antimicrob Chemother 2006;58(2):372-9
  • Acosta EP, Brundage RC, King JR, et al. National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group. Ganciclovir population pharmacokinetics in neonates following intravenous administration of ganciclovir and oral administration of a liquid valganciclovir formulation. Clin Pharmacol Ther 2007;81(6):867-72
  • Krekels EH, DeJongh J, van Lingen RA, et al. Predictive performance of a recently developed population pharmacokinetic model for morphine and its metabolites in new datasets of (preterm) neonates, infants, and children. Clin Pharmacokinet 2011;50(1):51-63
  • De Cock R, Allegaert K, Schreuder MF, et al. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet 2012;51(2):105-17
  • Carpenter KH, Wiley V. Application of tandem mass spectrometry to biochemical genetics and newborn screening. Clin Chim Acta 2002;322(1-2):1-10
  • Patel P, Mull H, Tanna S, Pandya H. Facilitating pharmacokinetic studies in children: a new use of dried blood spots. Arch Dis Child 2010;95(6):484-7
  • Li W, Tse FL. Dried blood spot sampling in combination with LC-MS/MS for quantitative analysis of small molecules. Biomed Chromatogr 2010;24(1):49-65
  • Edelbroek PM, van der Heijden J, Stolk LM. Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther Drug Monit 2009;31(3):327-36
  • Denniff P, Spooner N. The effect of hematocrit on assay bias when using DBS samples for the quantitative bioanalysis of drugs. Bioanalysis 2010;2(8):1385-95
  • Emmons G, Rowland M. Pharmacokinetic considerations as to when to use dried blood spot sampling. Bioanalysis 2010;2(11):1791-6
  • Spooner N, Lad R, Barfield 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 2009;81(4):1557-63
  • Filippi L, la Marca G, Fiorini P, et al. Topiramate concentrations in neonates treated with prolonged whole body hypothermia for hypoxic ischemic encephalopathy. Epilepsia 2009;50(11):2355-61
  • Filippi L, la Marca G, Cavallaro G, et al. Phenobarbital for neonatal seizures in hypoxic ischemic encephalopathy: a pharmacokinetic study during whole body hypothermia. Epilepsia 2011;52(4):794-801
  • Patel P, Mulla H, Kairamkonda V, et al. Dried blood spots and sparse sampling: a practical approach to estimating pharmacokinetic parameters of caffeine in preterm infants. Br J Clin Pharmacol 2013;75(3):805-13
  • Della Bona ML, Malvagia S, Villanelli F, et al. A rapid liquid chromatography tandem mass spectrometry-based method for measuring propranolol on dried blood spots. J Pharm Biomed Anal 2013;78-79:34-8
  • Suyagh M, Collier PS, Millership JS, et al. Metronidazole population pharmacokinetics in preterm neonates using dried blood-spot sampling. Pediatrics 2011;127(2):e367-74
  • Cohen-Wolkowiez M, Benjamin DK Jr, Ross A, et al. Population pharmacokinetics of piperacillin using scavenged samples from preterm infants. Ther Drug Monit 2012;34(3):312-19
  • Nováková L, Vlčková H. A review of current trends and advances in modern bio-analytical methods: chromatography and sample preparation. Anal Chim Acta 2009;656(1-2):8-35
  • Musteata FM, Pawliszyn J. In vivo sampling with solid phase microextraction. J Biochem Biophys Methods 2007;70(2):181-93
  • Katoaka H. Current developments and future trends in solid-phase microextraction techniques for pharmaceutical and biomedical analyses. Anal Sci 2011;27(9):893-905
  • Kataoka H, Saito K. Recent advances in SPME techniques in biomedical analysis. J Pharm Biomed Anal 2011;54(5):926-50
  • Millership JS. Microassay of drugs and modern measurements techniques. Paediatr Anaesth 2011;21(3):197-205
  • Chaurasia CS, Müller M, Bashaw ED, et al. AAPS-FDA Workshop White Paper: microdialysis principles, application, and regulatory perspectives. Pharm Res 2007;24(5):1014-25
  • Müller M. Microdialysis in clinical drug delivery studies. Adv Drug Deliv Rev 2000;45(2-3):255-69
  • Cano-Cebrian MJ, Zornova T, Polache A, Grandero L. Quantitative in vivo microdialysis in pharmacokinetic studies: some reminders. Curr Drug Metab 2005;6(2):83-90
  • Brunner M, Derendorf H, Müller M. Microdialysis for in vivo pharmacokinetic/pharmacodynamic characterization of anti-infective drugs. Curr Opin Pharmacol 2005;5(5):495-9
  • Richards DA, Tolias CM, Sgouros S, Bowery NG. Extracellular glutamine to glutamate ratio may predict outcome in the injured brain: a clinical microdialysis study in children. Pharmacol Res 2003;48(1):101-9
  • Baumeister FA, Rolinski B, Busch R, Emmrich P. Glucose monitoring with long-term subcutaneous microdialysis in neonates. Pediatrics 2001;108(5):1187-92
  • Rolinski B, Baumeister FA, Roscher AA. Determination of amino acid tissue concentrations by microdialysis: method evaluation and relation to plasma values. Amino Acids 2001;21(2):129-38
  • Hack A, Busch V, Pascher B, et al. Monitoring of ketogenic diet for carnitine metabolites by subcutaneous microdialysis. Pediatr Res 2006;60(1):93-6
  • Hildingsson U, Lönnqvist PA, Sellden H, et al. Age-dependent variations in white adipose tissue glycerol and lactate production after surgery measured by microdialysis in neonates and children. Paediatr Anaesth 2000;10(3):283-9
  • van den Heuvel I, Vlasselaers D, Wouters PJ, et al. Serial lactate measurements using microdialysis of interstitial fluid do not correlate with plasma lactate in children after cardiac surgery. Pedaitr Crit Care Med 2009;10(1):66-70
  • Hack A, Busch V, Gempel K, Baumeister FA. Subcutaneous microdialysis for children – safe biochemical tissue monitoring based on a minimal traumatizing no touch insertion technique. Eur J Med Res 2005;10(10):419-25
  • Rodriguez-Aller M, Gurny R, Veuthey JL, Guillarme D. Coupling ultra high-pressure liquid chromatography with mass spectrometry: constraints and possible applications. J Chromatogr A 2013;1292:2-18
  • Déglon J, Thomas A, Mangin P, Staub C. Direct analysis of dried blood spots coupled with mass spectrometry: concepts and biomedical applications. Anal Bioanal Chem 2012;402(8):2485-98
  • Lee JW, Kelley M, King LE, et al. Bioanalytical approaches to quantify “total” and “free” therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J 2011;13(1):99-110
  • Zhang Y, Mehrotra N, Budha NR, et al. A tandem mass spectrometry assay for the simultaneous determination of acetaminophen, caffeine, phenytoin, ranitidine, and theophylline in small volume pediatric plasma specimens. Clin Chim Acta 2008;398(1-2):105-12
  • Ahsman MJ, Wildschut ED, Tibboel D, Mathot RA. Microanalysis of beta-lactam antibiotics and vancomycin in plasma for pharmacokinetic studies in neonates. Antimicrob Agents Chemother 2009;53(1):75-80
  • Clavijo CF, Hoffman KL, Thomas JJ, et al. A sensitive assay for the quantification of morphine and its active metabolites in human plasma and dried blood spots using high-performance liquid chromatography-tandem mass spectrometry. Anal Bioanal Chem 2011;400(3):715-28
  • Cohen-Wolkowiez M, White NR, Bridges A, et al. Developments of a liquid chromatography-tandem mass spectrometry assay of six antimicrobials in plasma for pharmacokinetic studies in premature infants. J Chromatogr B Analyt Technol Biomed Life Sci 2011;879(30):3497-506
  • Knibbe CA, Krekels EH, Danhof M. Advances in paediatric pharmacokinetics. Expert Opin Drug Metab Toxicol 2011;7(1):1-8
  • Bellanti F, Della Pasqua O. Modelling and simulation as research tools in paediatric drug development. Eur J Clin Pharmacol 2011;67(Suppl 1):S75-86
  • Meibohm B, Läer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J 2005;7(2):E475-87
  • Mahmood I. Theoretical versus empirical allometry: facts behind theories and application to pharmacokinetics. J Pharm Sci 2010;99(7):2927-33
  • Hu TM, Hayton WL. Allometric scaling of xenobiotic clearance: uncertainty versus universality. AAPS PharmSci 2001;3(4):E29
  • Wang C, Allegaert K, Peeters M, et al. The allometric exponent for scaling clearance varies with age: a study on seven propofol datasets ranging from preterm neonates to adults. Br J Clin Pharmacol 2014;77(1):149-59
  • Edginton AN, Shah B, Sevestre M, Momper JD. The integration of allometry and virtual populations to predict clearance and clearance variability in pediatric populations over the age of 6 years. Clin Pharmacokinet 2013;52(8):693-703
  • Food and Drug Administration Center for Drug Evaluation and Research; Summary Minutes of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. 2012. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/UCM306989.pdf [Last accessed 10 November 2013]
  • Marsot A, Boulamery A, Bruguerolle B, Simon N. Population pharmacokinetic analysis during the first 2 years of life. Clin Pharmacokinet 2012;51(12):787-98
  • Krekels EHJ, Neely M, Panoilia E, et al. From pediatric covariate model to semiphysiological function for maturation: part I – extrapolation of a covariate model from morphine to zidovudine. CPT Pharmacometrics Sys Pharmacol 2012;1(e9):1-9
  • Krekels EHJ, Johnson TN, den Hoedt SM, et al. From pediatric covariate model to semiphysiological function for maturation: part II – sensitivity to physiological and physicochemical properties. CPT Pharmacometrics Sys Pharmacol 2012;1(e10):1-10
  • De Cock RF, Allegaert K, Sherwin CM, et al. A neonatal amikacin covariate model can be used to predict ontogeny of other drugs eliminated through glomerular filtration in neonates. Pharm Res 2013; Epub ahead of print
  • Zhao W, Biran V, Jacqz-Aigrain E. Amikacin maturation model as a marker of renal maturation to predict glomerular filtration rate and vancomycin clearance in neonates. Clin Pharmacokinet 2013; Epub ahead of print
  • De Cock RF, Piana C, Krekels EH, et al. The role of population PK-PD modeling in paediatric clinical research. Eur J Clin Pharmacol 2011;67(Suppl 1):S5-16
  • Sherwin CMT, Kiang TKL, Spigarelli MG, Ensom MH. Fundamentals of population pharmacokinetic modeling: validation methods. Clin Pharmacokinet 2012;51(9):573-90
  • Edginton AN. Knowledge-driven approaches for the guidance of first-in-children dosing. Paediatr Anaesth 2011;21(3):206-13
  • Barrett JS, Della Casa Alberighi O, Läer S, Meibohm B. Physiologically based pharmacokinetic (PBPK) modeling in children. Clin Pharmacol Ther 2012;92(1):40-9
  • Khalil F, Läer S. Physiologically based pharmacokinetic modeling: methodology, applications, and limitations with a focus on its role in pediatric drug development. J Biomed Biotechnol 2011;2011:1-13
  • Johnson TN, Rostami-Hodjegan A. Resurgence in the use of physiologically based pharmacokinetic models in pediatric clinical pharmacology: parallel shift in incorporating the knowledge of biological elements and increased applicability to drug development and clinical practice. Paediatr Anaesth 2011;21(3):291-301
  • Björkman S. Prediction of drug disposition in infants and children by means of physiologically based pharmacokinetic (PBPK) modeling: theophylline and midazolam as model drugs. Br J Clin Pharmacol 2005;59(6):691-704
  • Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 2006;45(9):931-56
  • Anderson BJ, Larsson P. A maturation model for midazolam clearance. Paediatr Anaesth 2011;21(3):302-8
  • Ince I, de Wildt SN, Peeters MY, et al. Critical illness is a major determinant of midazolam clearance in children aged 1 month to 17 years. Ther Drug Monit 2012;34(4):381-9
  • Gobburu JV, Lesko LJ. Quantitative disease, drug, and trial models. Annu Rev Pharmacol Toxicol 2009;49:291-301
  • Girard P. Clinical trial simulation: a tool for understanding study failures and preventing them. Basic Clin Pharmacol Toxicol 2005;96(3):228-34
  • Holford N, Ma SC, Ploeger BA. Clinical trial simulation: a review. Clin Pharmacol Ther 2010;88(2):166-82
  • Reif S, Schultze-Mosgau M, Sutter G. From adults to children: simulation-based choice of an appropriate sparse-sampling schedule. Paediatr Drugs 2012;14(3):189-200
  • Sherwin CM, Ding L, Kaplan J, et al. Optimal study design for pioglitazone in septic pediatric patients. J Pharmacokinet Pharmacodyn 2011;38(4):433-47
  • Barrett JS, Fossler MJ, Cadieu KD, Gastonguay MR. Pharmacometrics: a multidisciplinary field to facilitate critical thinking in drug development and translational research settings. J Clin Pharmacol 2008;48(5):632-49
  • Anderson BJ, Merry AF. Data sharing for pharmacokinetic studies. Paedaitr Anaesth 2009;19(10):1005-10
  • Ince I, de Wildt SN, Tibboel D, et al. Tailor-made drug treatment for children: creation of an infrastructure for data-sharing and population PK-PD modeling. Drug Discov Today 2009;14(5-6):316-20
  • Carcillo JA, Doughty L, Kofos D, et al. Cytochrome P450 mediated-drug metabolism is reduced in children with sepsis-induced multiple organ failure. Intensive Care Med 2003;29(6):980-4
  • Läer S, Barrett JS, Meibohm B. The in silico child: using simulation to guide pediatric drug development and manage pediatric pharmacotherapy. J Clin Pharmacol 2009;49(8):889-904

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.