Pharmacokinetic studies in infants using minimal-risk study designs

Current Clinical Pharmacology

Volumn 9, Issue 4, 2014, Pages 350-358

  Autmizguine, Julie ^a,b   Benjamin, Daniel K ^a   Brian Smith, P ^a   Sampson, Mario ^a   Ovetchkine, Philippe ^b   Cohen Wolkowiez, Michael ^a   Watt, Kevin M ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b UNIVERSITY OF MONTREAL   (Canada)

Author keywords

Clinical trial; Dried blood spots; Infants; Pharmacokinetics; Population pharmacokinetics; Scavenged sampling; Sparse sampling; Ultra low volume drug assays

Indexed keywords

ARTICLE; BLOOD ANALYSIS; DRIED BLOOD SPOT TESTING; DRIED MATRIX SPOT SAMPLING; DRUG DISPOSITION; EXHALATION; EXHALED BREATH; HUMAN; INFANT; MATHEMATICAL MODEL; MICROANALYSIS; MICRODOSING; MULTICENTER STUDY (TOPIC); PHARMACOKINETICS; PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PROSPECTIVE STUDY; SALIVA ANALYSIS; SIMULATION; STUDY DESIGN; ULTRA LOW VOLUME DRUG ASSAY; BIOLOGICAL MODEL; CLINICAL TRIAL (TOPIC); COMPUTER SIMULATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; METHODOLOGY; PROCEDURES;

CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; INFANT; MODELS, BIOLOGICAL; PHARMACOKINETICS; RESEARCH DESIGN;

EID: 84922359025     PISSN: 15748847     EISSN: None     Source Type: Journal    
DOI: 10.2174/1574884709666140520153308     Document Type: Article

References (128)

1. [1] Administration USFaD. New Pediatric Labeling Information Database. 2013[Accessed 2013 July 20]; Available from: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelin gdatabase.
2. [2] Sisson TR, Lund CJ, Whalen LE, Telek A. The blood volume of infants. I. The full-term infant in the first year of life. J Pediatr 1959; 55(2): 163-79.
3. [3] Bauer K, Linderkamp O, Versmold HT. Systolic blood pressure and blood volume in preterm infants. Arch Dis Child 1993; 69(5 Spec No): 521-2.
4. [4] Zhang Y, Mehrotra N, Budha NR, Christensen ML, Meibohm B. 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.
5. [5] 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.
6. [6] Cohen-Wolkowiez M, White NR, Bridges A, Benjamin DK Jr, Kashuba AD. Development 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.
7. [7] Pullen J, Stolk LM, Neef C, Zimmermann LJ. Microanalysis of amoxicillin, flucloxacillin, and rifampicin in neonatal plasma. Biomed Chromatogr 2007; 21(12): 1259-65.
8. [8] Smith PB, Cohen-Wolkowiez M, Castro LM, et al. Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections. Pediatr Infect Dis J 2011; 30(10): 844-9.
9. [9] 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): 312-9.
10. [10] 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.
11. [11] Guthrie R, Susi A. A simple phenylalanine method for detecting phenylketonuria in large populations of newborn infants. Pediatrics 1963; 32: 338-43.
12. [12] Ansari M, Uppugunduri CR, Deglon J, et al. A simplified method for busulfan monitoring using dried blood spot in combination with liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom 2012; 26(12): 1437-46.
13. [13] Cheung CY, van der Heijden J, Hoogtanders K, et al. Dried blood spot measurement: application in tacrolimus monitoring using limited sampling strategy and abbreviated AUC estimation. Transpl Int 2008; 21(2): 140-5.
14. [14] 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.
15. [15] Suyagh MF, Iheagwaram G, Kole PL, et al. Development and validation of a dried blood spot-HPLC assay for the determination of metronidazole in neonatal whole blood samples. Anal Bioanal Chem 2010; 397(2): 687-93.
16. [16] Patel P, Tanna S, Mulla H, Kairamkonda V, Pandya H, Lawson G. Dexamethasone quantification in dried blood spot samples using LC-MS: The potential for application to neonatal pharmacokinetic studies. J Chromatogr B Analyt Technol Biomed Life Sci 2010; 878(31): 3277-82.
17. [17] 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.
18. [18] Patel P, Mulla 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.
19. [19] Cohen-Wolkowiez M, Sampson M, Bloom BT, et al. Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants. Pediatr Infect Dis J 2013.
20. [20] 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.
21. [21] Ludwig E, Csiba A, Magyar T, Garbe H. Uptake of metronidazole by human erythrocytes. Acta Med Acad Sci Hung 1981; 38(2): 163-70.
22. [22] Barfield M, Wheller R. Use of dried plasma spots in the determination of pharmacokinetics in clinical studies: validation of a quantitative bioanalytical method. Anal Chem 2011; 83(1): 118-24.
23. [23] Blessborn D, Skold K, Zeeberg D, Kaewkhao K, Skold O, Ahnoff M. Heat stabilization of blood spot samples for determination of metabolically unstable drug compounds. Bioanalysis 2013; 5(1): 31-9.
24. [24] 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.
25. [25] Health ADo. Newborn Screening in Arkansas SFY112012; http://www.healthy.arkansas.gov/programsServices/familyHealth/Child AndAdolescentHealth/newBornScreening/HealthProfessionals/Doc uments/NBSReportSFY2011.pdf].
26. [26] Holford NH. A size standard for pharmacokinetics. Clin Pharmacokinet 1996; 30(5): 329-32.
27. [27] 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.
28. [28] 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.
29. [29] Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin Pharmacokinet 2008; 47(4): 231-43.
30. [30] Marsot A, Boulamery A, Bruguerolle B, Simon N. Population pharmacokinetic analysis during the first 2 years of life: an overview. Clin Pharmacokinet 2012; 51(12): 787-98.
31. [31] Edginton AN, Schmitt W, Willmann S. Development and evaluation of a generic physiologically based pharmacokinetic model for children. Clin Pharmacokinet 2006; 45(10): 1013-34.
32. [32] Zhao P, Zhang L, Grillo JA, et al. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin Pharmacol Ther 2011; 89(2): 259-67.
33. [33] Leong R, Vieira ML, Zhao P, et al. Regulatory experience with physiologically based pharmacokinetic modeling for pediatric drug trials. Clin Pharmacol Ther 2012; 91(5): 926-31.
34. [34] Dumont C, Mentre F, Gaynor C, Brendel K, Gesson C, Chenel M. Optimal sampling times for a drug and its metabolite using SIMCYP((R)) simulations as prior information. Clin Pharmacokinet 2013; 52(1): 43-57.
35. [35] Croom EL, Stevens JC, Hines RN, Wallace AD, Hodgson E. Human hepatic CYP2B6 developmental expression: the impact of age and genotype. Biochem Pharmacol 2009; 78(2): 184-90.
36. [36] Tateishi T, Nakura H, Asoh M, et al. A comparison of hepatic cytochrome P450 protein expression between infancy and postinfancy. Life Sci 1997; 61(26): 2567-74.
37. [37] Bjorkman S. Prediction of drug disposition in infants and children by means of physiologically based pharmacokinetic (PBPK) modelling: theophylline and midazolam as model drugs. Br J Clin Pharmacol 2005; 59(6): 691-704.
38. [38] Barrett JS, Della Casa Alberighi O, Laer S, Meibohm B. Physiologically based pharmacokinetic (PBPK) modeling in children. Clin Pharmacol Ther 2012; 92(1): 40-9.
39. [39] Poulin P, Jones RD, Jones HM, et al. PHRMA CPCDC initiative on predictive models of human pharmacokinetics, part 5: Prediction of plasma concentration-time profiles in human by using the physiologically-based pharmacokinetic modeling approach. J Pharm Sci 2011.
40. [40] Strougo A, Eissing T, Yassen A, Willmann S, Danhof M, Freijer J. First dose in children: physiological insights into pharmacokinetic scaling approaches and their implications in paediatric drug development. J Pharmacokinet Pharmacodyn 2012; 39(2): 195-203.
41. [41] FDA CfDEaR. Summary Minutes of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology 2012 [Accessed 2013 July 19 2013]; Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Advisory CommitteeforPharmaceuticalScienceandClinicalPharmacology/UC M306989.pdf.
42. [42] Guidance for industry – general considerations for pediatric pharmacokinetic studies for drugs and biological products, 1998.
43. [43] Pediatric Regulation, 2006.
44. [44] Guidance for Industry Population Pharmacokinetics, 1999.
45. [45] Acosta EP, Jester P, Gal P, et al. Oseltamivir dosing for influenza infection in premature neonates. J Infect Dis. 2010; 202(4): 563-6.
46. [46] Standing JF, Nika A, Tsagris V, et al. Oseltamivir pharma-cokinetics and clinical experience in neonates and infants during an outbreak of H1N1 influenza A virus infection in a neonatal intensive care unit. Antimicrob Agents Chemother 2012; 56(7): 3833-40.
47. [47] Wade KC, Wu D, Kaufman DA, et al. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother 2008; 52(11): 4043-9.
48. [48] Lee TC, Charles B, Steer P, Flenady V, Shearman A. Population pharmacokinetics of intravenous caffeine in neonates with apnea of prematurity. Clin Pharmacol Ther 1997; 61(6): 628-40.
49. [49] Thomson AH, Kerr S, Wright S. Population pharmacokinetics of caffeine in neonates and young infants. Ther Drug Monit 1996; 18(3): 245-53.
50. [50] Rauh M, Stachel D, Kuhlen M, Groschl M, Holter W, Rascher W. Quantification of busulfan in saliva and plasma in haematopoietic stem cell transplantation in children: validation of liquid chromato-graphy tandem mass spectrometry method. Clin Pharmacokinet 2006; 45(3): 305-16.
51. [51] Aman MG, Vinks AA, Remmerie B, et al. Plasma pharmacokinetic characteristics of risperidone and their relationship to saliva concentrations in children with psychiatric or neurodevelopmental disorders. Clin Ther 2007; 29(7): 1476-86.
52. [52] Gordi T, Hai TN, Hoai NM, Thyberg M, Ashton M. Use of saliva and capillary blood samples as substitutes for venous blood sampling in pharmacokinetic investigations of artemisinin. Eur J Clin Pharmacol 2000; 56(8): 561-6.
53. [53] Hornuss C, Praun S, Villinger J, et al. Real-time monitoring of propofol in expired air in humans undergoing total intravenous anesthesia. Anesthesiology 2007; 106(4): 665-74.
54. [54] van den Anker JN, Pokorna P, Kinzig-Schippers M, et al. Meropenem pharmacokinetics in the newborn. Antimicrob Agents Chemother 2009; 53(9): 3871-9.
55. [55] Burgen AS. The secretion of non-electrolytes in the parotid saliva. J Cell Physiol 1956; 48(1): 113-38.
56. [56] de Gier JJ, t Hart BJ, Wilderink PF, Nelemans FA. Comparison of plasma and saliva levels of diazepam. Br J Clin Pharmacol 1980; 10(2): 151-5.
57. [57] Killmann SA, Thaysen JH. The permeability of the human parotid gland to a series of sulfonamide compounds, para-aminohippurate and inulin. Scand J Clin Lab Invest 1955; 7(1): 86-91.
58. [58] Wood JH, Flora KP, Narasimhachari N, Baker CA. Dependence of salivary drug concentration on salivary flow rate. Methods Find Exp Clin Pharmacol 1982; 4(4): 255-60.
59. [59] Bartels H, Gunther E, Wallis S. Flow-dependent salivary primidone levels in epileptic children. Epilepsia 1979; 20(4): 431-6.
60. [60] de Wildt SN, Kerkvliet KT, Wezenberg MG, et al. Use of saliva in therapeutic drug monitoring of caffeine in preterm infants. Ther Drug Monit 2001; 23(3): 250-4.
61. [61] Ginsburg CM, McCracken GH Jr, Thomas ML, Clahsen J. Comparative pharmacokinetics of amoxicillin and ampicillin in infants and children. Pediatrics 1979; 64(5): 627-31.
62. [62] Gorodischer R, Burtin P, Hwang P, Levine M, Koren G. Saliva versus blood sampling for therapeutic drug monitoring in children: patient and parental preferences and an economic analysis. Ther Drug Monit 1994; 16(5): 437-43.
63. [63] Amon I, Amon K, Scharp H, Franke G, Nagel F. Disposition kinetics of metronidazole in children. Eur J Clin Pharmacol 1983; 24(1): 113-9.
64. [64] Klein P, Herr D, Pearl PL, et al. Results of phase II pharmacokinetic study of levetiracetam for prevention of post-traumatic epilepsy. Epilepsy Behav 2012; 24(4): 457-61.
65. [65] Hornuss C, Wiepcke D, Praun S, Dolch ME, Apfel CC, Schelling G. Time course of expiratory propofol after bolus injection as measured by ion molecule reaction mass spectrometry. Anal Bioanal Chem 2012; 403(2): 555-61.
66. [66] Hornuss C Praun S, Villinger J, Kuhnle G, Schelling G, editor. Real-Time monitoring of propofol in expiratory air in children during total intravenous anesthesia. Am Soc Anesthesiologists Ann Meeting San Francisco 2007.
67. [67] FDA CfDEaR. Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies. 2006[Accessed 2013 November 8th, 2013]; Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm07893 3.pdf.
68. [68] Vogel JS, Love AH. Quantitating isotopic molecular labels with accelerator mass spectrometry. Methods Enzymol 2005; 402: 402-22.
69. [69] Yamazaki A, Kumagai Y, Yamane N, et al. Microdose study of a P-glycoprotein substrate, fexofenadine, using a non-radioisotope-labelled drug and LC/MS/MS. J Clin Pharm Ther 2010; 35(2): 169-75.
70. [70] Tozuka Z, Kusuhara H, Nozawa K, et al. Microdose study of 14C-acetaminophen with accelerator mass spectrometry to examine pharmacokinetics of parent drug and metabolites in healthy subjects. Clin Pharmacol Ther 2010; 88(6): 824-30.
71. [71] Boulton DW, Kasichayanula S, Keung CF, et al. Simultaneous oral therapeutic and intravenous (1)(4)C-microdoses to determine the absolute oral bioavailability of saxagliptin and dapagliflozin. Br J Clin Pharmacol 2013; 75(3): 763-8.
72. [72] Lappin G, Kuhnz W, Jochemsen R, et al. Use of microdosing to predict pharmacokinetics at the therapeutic dose: experience with 5 drugs. Clin Pharmacol Ther 2006; 80(3): 203-15.
73. [73] Baillie R GT, Bosley J, Blood A, Vasquez H, Vuong L. Accelerator Mass Spectrometry (AMS) Enables Pediatric PK/PD Analysis in a Neonate Clinical Trial 2009.
74. [74] EMEA Cfpmp. Position paper on non-clinical safety studies to support clinical trials with a single microdose. 2003; Available from: http://www.iaa-ams.co.jp/img_bsnss/MD1.pdf.
75. [75] Tod M, Lokiec F, Bidault R, De Bony F, Petitjean O, Aujard Y. Pharmacokinetics of oral acyclovir in neonates and in infants: a population analysis. Antimicrob Agents Chemother 2001; 45(1): 150-7.
76. [76] Bleyzac N, Varnier V, Labaune JM, et al. Population pharmacokinetics of amikacin at birth and interindividual variability in renal maturation. Eur J Clin Pharmacol 2001; 57(6-7): 499-504.
77. [77] Allegaert K, Scheers I, Adams E, Brajanoski G, Cossey V, Anderson BJ. Cerebrospinal fluid compartmental pharmacokinetics of amikacin in neonates. Antimicrob Agents Chemother 2008; 52(6): 1934-9.
78. [78] Allegaert K, Anderson BJ, Cossey V, Holford NH. Limited predictability of amikacin clearance in extreme premature neonates at birth. Br J Clin Pharmacol 2006; 61(1): 39-48.
79. [79] Botha JH, du Preez MJ, Miller R, Adhikari M. Determination of population pharmacokinetic parameters for amikacin in neonates using mixed-effect models. Eur J Clin Pharmacol 1998; 53(5): 337-41.
80. [80] Pullen J, Stolk LM, Nieman FH, Degraeuwe PL, van Tiel FH, Zimmermann LJ. Population pharmacokinetics and dosing of amoxicillin in (pre)term neonates. Ther Drug Monit 2006; 28(2): 226-31.
81. [81] Falcao AC, Fernandez de Gatta MM, Delgado Iribarnegaray MF, et al. Population pharmacokinetics of caffeine in premature neonates. Eur J Clin Pharmacol 1997; 52(3): 211-7.
82. [82] Lima-Rogel V, Medina-Rojas EL, Del Carmen Milan-Segovia R, et al. Population pharmacokinetics of cefepime in neonates with severe nosocomial infections. J Clin Pharm Ther 2008; 33(3): 295-306.
83. [83] Payen S, Serreau R, Munck A, et al. Population pharmacokinetics of ciprofloxacin in pediatric and adolescent patients with acute infections. Antimicrob Agents Chemother 2003; 47(10): 3170-8.
84. [84] Preechagoon Y, Charles B, Piotrovskij V, Donovan T, Van Peer A. Population pharmacokinetics of enterally administered cisapride in young infants with gastro-oesophageal reflux disease. Br J Clin Pharmacol 1999; 48(5): 688-93.
85. [85] Odoul F, Le Guellec C, Henrot A, et al. Population pharmacokinetics of cisapride in neonates. Eur J Clin Pharmacol 2002; 58(8): 507-13.
86. [86] Xie HG, Cao YJ, Gauda EB, Agthe AG, Hendrix CW, Lee H. Clonidine clearance matures rapidly during the early postnatal period: a population pharmacokinetic analysis in newborns with neonatal abstinence syndrome. J Clin Pharmacol 2011; 51(4): 502-11.
87. [87] Martin-Suarez A, Falcao AC, Outeda M, et al. Population pharmacokinetics of digoxin in pediatric patients. Ther Drug Monit 2002; 24(6): 742-5.
88. [88] Suematsu F, Yukawa E, Yukawa M, et al. Population-based investigation of relative clearance of digoxin in Japanese neonates and infants by multiple-trough screen analysis. Eur J Clin Pharmacol 2001; 57(1): 19-24.
89. [89] Dailly E, Drouineau MH, Gournay V, Roze JC, Jolliet P. Population pharmacokinetics of domperidone in preterm neonates. Eur J Clin Pharmacol 2008; 64(12): 1197-200.
90. [90] Hirt D, Urien S, Rey E, et al. Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Antimicrob Agents Chemother 2009; 53(3): 1067-73.
91. [91] Pullen J, de Rozario L, Stolk LM, Degraeuwe PL, van Tiel FH, Zimmermann LJ. Population pharmacokinetics and dosing of flucloxacillin in preterm and term neonates. Ther Drug Monit 2006; 28(3): 351-8.
92. [92] Garcia B, Barcia E, Perez F, Molina IT. Population pharmacokinetics of gentamicin in premature newborns. J Antimicrob Chemother 2006; 58(2): 372-9.
93. [93] Lanao JM, Calvo MV, Mesa JA, et al. Pharmacokinetic basis for the use of extended interval dosage regimens of gentamicin in neonates. J Antimicrob Chemother 2004; 54(1): 193-8.
94. [94] Botha JH, du Preez MJ, Adhikari M. Population pharmacokinetics of gentamicin in South African newborns. Eur J Clin Pharmacol 2003; 59(10): 755-9.
95. [95] Thomson AH, Kokwaro GO, Muchohi SN, English M, Mohammed S, Edwards G. Population pharmacokinetics of intramuscular gentamicin administered to young infants with suspected severe sepsis in Kenya. Br J Clin Pharmacol 2003; 56(1): 25-31.
96. [96] Izquierdo M, Lanao JM, Cervero L, Jimenez NV, Dominguez-Gil A. Population pharmacokinetics of gentamicin in premature infants. Ther Drug Monit 1992; 14(3): 177-83.
97. [97] Jensen PD, Edgren BE, Brundage RC. Population pharmacokinetics of gentamicin in neonates using a nonlinear, mixed-effects model. Pharmacotherapy 1992; 12(3): 178-82.
98. [98] Thomson AH, Way S, Bryson SM, McGovern EM, Kelman AW, Whiting B. Population pharmacokinetics of gentamicin in neonates. Dev Pharmacol Ther 1988; 11(3): 173-9.
99. [99] Weber W, Kewitz G, Rost KL, Looby M, Nitz M, Harnisch L. Population kinetics of gentamicin in neonates. Eur J Clin Pharmacol 1993; 44(Suppl 1): S23-5.
100. [100] DiCenzo R, Forrest A, Slish JC, Cole C, Guillet R. A gentamicin pharmacokinetic population model and once-daily dosing algorithm for neonates. Pharmacotherapy 2003; 23(5): 585-91.
101. [101] Gregoire N, Gualano V, Geneteau A, et al. Population pharmacokinetics of ibuprofen enantiomers in very premature neonates. J Clin Pharmacol 2004; 44(10): 1114-24.
102. [102] Hirt D, Van Overmeire B, Treluyer JM, et al. An optimized ibuprofen dosing scheme for preterm neonates with patent ductus arteriosus, based on a population pharmacokinetic and pharmacodynamic study. Br J Clin Pharmacol 2008; 65(5): 629-36.
103. [103] Al Zaabi M, Donovan T, Tudehope D, Woodgate P, Collie LA, Charles B. Orogastric and intravenous indomethacin administration to very premature neonates with patent ductus arteriosus: population pharmacokinetics, absolute bioavailability, and treatment outcome. Ther Drug Monit 2007; 29(6): 807-14.
104. [104] Zuppa AF, Mondick JT, Davis L, Cohen D. Population pharma-cokinetics of ketorolac in neonates and young infants. Am J Ther 2009; 16(2): 143-6.
105. [105] Simons FE. Population pharmacokinetics of levocetirizine in very young children: the pediatricians' perspective. Pediatr Allergy Immunol. 2005; 16(2): 97-103.
106. [106] Hussein Z, Pitsiu M, Majid O, Aarons L, de Longueville M, Stockis A. Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: the ETAC study. Br J Clin Pharmacol 2005; 59(1): 28-37.
107. [107] Bradley JS, Sauberan JB, Ambrose PG, Bhavnani SM, Rasmussen MR, Capparelli EV. Meropenem pharmacokinetics, pharma-codynamics, and Monte Carlo simulation in the neonate. Pediatr Infect Dis J 2008; 27(9): 794-9.
108. [108] Hope WW, Smith PB, Arrieta A, et al. Population pharma-cokinetics of micafungin in neonates and young infants. Antimicrob Agents Chemother 2010; 54(6): 2633-7.
109. [109] Harte GJ, Gray PH, Lee TC, Steer PA, Charles BG. Haemodynamic responses and population pharmacokinetics of midazolam following administration to ventilated, preterm neonates. J Paediatr Child Health 1997; 33(4): 335-8.
110. [110] Burtin P, Jacqz-Aigrain E, Girard P, et al. Population pharma-cokinetics of midazolam in neonates. Clin Pharmacol Ther 1994; 56(6 Pt 1): 615-25.
111. [111] Bailey JM, Hoffman TM, Wessel DL, et al. A population pharmacokinetic analysis of milrinone in pediatric patients after cardiac surgery. J Pharmacokinet Pharmacodyn 2004; 31(1): 43-59.
112. [112] Fattinger K, Vozeh S, Olafsson A, Vlcek J, Wenk M, Follath F. Netilmicin in the neonate: population pharmacokinetic analysis and dosing recommendations. Clin Pharmacol Ther 1991; 50(1): 55-65.
113. [113] Benaboud S, Ekouevi DK, Urien S, et al. Population pharmacokinetics of nevirapine in HIV-1-infected pregnant women and their neonates. Antimicrob Agents Chemother 2011; 55(1): 331-7.
114. [114] Grasela TH Jr., Donn SM. Neonatal population pharmacokinetics of phenobarbital derived from routine clinical data. Dev Pharmacol Ther 1985; 8(6): 374-83.
115. [115] Yukawa M, Yukawa E, Suematsu F, et al. Population pharmacokinetics of phenobarbital by mixed effect modelling using routine clinical pharmacokinetic data in Japanese neonates and infants: an update. J Clin Pharm Ther 2011; 36(6): 704-10.
116. [116] Wilmshurst JM, van der Walt JS, Ackermann S, Karlsson MO, Blockman M. Rescue therapy with high-dose oral phenobarbitone loading for refractory status epilepticus. J Paediatr Child Health 2010; 46(1-2): 17-22.
117. [117] Al Za'abi M, Lanner A, Xiaonian X, Donovan T, Charles B. Application of routine monitoring data for determination of the population pharmacokinetics and enteral bioavailability of phenytoin in neonates and infants with seizures. Ther Drug Monit 2006; 28(6): 793-9.
118. [118] Rapp HJ, Molnar V, Austin S, et al. Ropivacaine in neonates and infants: a population pharmacokinetic evaluation following single caudal block. Paediatr Anaesth 2004; 14(9): 724-32.
119. [119] Hirt D, Urien S, Ekouevi DK, et al. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109). Clin Pharmacol Ther 2009; 85(2): 182-9.
120. [120] Fukuda T, Yukawa E, Kondo G, et al. Population pharmacokinetics of theophylline in very premature Japanese infants with apnoea. J Clin Pharm Ther 2005; 30(6): 591-6.
121. [121] Lee TC, Charles BG, Steer PA, Flenady VJ, Grant TC. Theophylline population pharmacokinetics from routine monitoring data in very premature infants with apnoea. Br J Clin Pharmacol 1996; 41(3): 191-200.
122. [122] de Hoog M, Schoemaker RC, Mouton JW, van den Anker JN. Tobramycin population pharmacokinetics in neonates. Clin Pharmacol Ther 1997; 62(4): 392-9.
123. [123] Falcao AC, Buelga DS, Mendez ME, Garcia MJ, Pardo M. Population kinetics of tobramycin in neonates. Ther Drug Monit 2001; 23(3): 202-8.
124. [124] Anderson BJ, Allegaert K, Van den Anker JN, Cossey V, Holford NH. Vancomycin pharmacokinetics in preterm neonates and the prediction of adult clearance. Br J Clin Pharmacol 2007; 63(1): 75-84.
125. [125] de Hoog M, Schoemaker RC, Mouton JW, van den Anker JN. Vancomycin population pharmacokinetics in neonates. Clin Pharmacol Ther 2000; 67(4): 360-7.
126. [126] Seay RE, Brundage RC, Jensen PD, Schilling CG, Edgren BE. Population pharmacokinetics of vancomycin in neonates. Clin Pharmacol Ther 1994; 56(2): 169-75.
127. [127] Asbury WH, Darsey EH, Rose WB, Murphy JE, Buffington DE, Capers CC. Vancomycin pharmacokinetics in neonates and infants: a retrospective evaluation. Ann Pharmacother 1993; 27(4): 490-6.
128. [128] Capparelli EV, Mirochnick M, Dankner WM, et al. Pharmacokinetics and tolerance of zidovudine in preterm infants. J Pediatr 2003; 142(1): 47-52.