First Dose in Neonates: Are Juvenile Mice, Adults and In Vitro–In Silico Data Predictive of Neonatal Pharmacokinetics of Fluconazole

Clinical Pharmacokinetics

Volumn 53, Issue 11, 2014, Pages 1005-1018

  Zhao, Wei ^a,b,c,d   Le Guellec, Chantal ^e   Benjamin, Daniel K ^f,g   Hope, William W ^h   Bourgeois, Thomas ^b   Watt, Kevin M ^f,g   van den Anker, Johannes N ^i,j,k,l   Matrot, Boris ^b   Saxen, Harri ^m   Hoppu, Kalle ^m   Manzoni, Paolo ⁿ   Jacqz Aigrain, Evelyne ^b,c,d  

^a SHANDONG UNIVERSITY   (China)

^b HÔPITAL ROBERT DEBRÉ   (France)

^c INSERM   (France)

^d UNIVERSITÉ PARIS DESCARTES   (France)

^e UNIVERSITÉ DE TOURS   (France)

^f DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^g DUKE UNIVERSITY MEDICAL CENTER   (United States)

^h UNIVERSITY OF LIVERPOOL   (United Kingdom)

ⁱ SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^j CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^k GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

^l UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^m HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

ⁿ S ANNA HOSPITAL   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

FLUCONAZOLE;

ADOLESCENT; ADULT; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; COMPUTER MODEL; COMPUTER SIMULATION; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG EXPOSURE; FEMALE; IN VITRO STUDY; INFANT; JUVENILE; KIDNEY; LETHAL DOSE; LIFESPAN; LOADING DRUG DOSE; MALE; MEASUREMENT ERROR; MOUSE; NEWBORN; NONHUMAN; NONMEM; PHARMACOLOGICAL PARAMETERS; PHYSICAL CHEMISTRY; PREDICTION; PRIORITY JOURNAL; SINGLE DRUG DOSE; STATISTICAL MODEL; VOLUME OF DISTRIBUTION; AFRICAN AMERICAN; ANIMAL; BAYES THEOREM; BIOLOGICAL MODEL; CAUCASIAN; HUMAN; PREDICTIVE VALUE;

ADOLESCENT; ADULT; AFRICAN AMERICANS; ANIMALS; ANIMALS, NEWBORN; BAYES THEOREM; COMPUTER SIMULATION; EUROPEAN CONTINENTAL ANCESTRY GROUP; FEMALE; FLUCONAZOLE; HUMANS; INFANT, NEWBORN; MALE; MICE; MODELS, BIOLOGICAL; PREDICTIVE VALUE OF TESTS;

EID: 84943015096     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-014-0169-7     Document Type: Article

References (49)

1. Purohit VS. Biopharmaceutic planning in pediatric drug development. AAPS J. 2012;14(3):519–22.
2. 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.
3. Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, et al. Role of modelling and simulation in pediatric investigation plans. Paediatr Anaesth. 2011;21(3):214–21.
4. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology—drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349(12):1157–67.
5. Johnson TN. Modelling approaches to dose estimation in children. Br J Clin Pharmacol. 2005;59(6):663–9.
6. Cella M, Gorter de Vries F, Burger D, Danhof M, Della Pasqua O. A model-based approach to dose selection in early pediatric development. Clin Pharmacol Ther. 2010;87(3):294–302.
7. Manzoni P, Stolfi I, Pugni L, Decembrino L, Magnani C, Vetrano G, et al. A multicenter, randomized trial of prophylactic fluconazole in preterm neonates. N Engl J Med. 2007;356(24):2483–95.
8. Kaufman D, Boyle R, Hazen KC, Patrie JT, Robinson M, Donowitz LG. Fluconazole prophylaxis against fungal colonization and infection in preterm infants. N Engl J Med. 2001;345(23):1660–6.
9. FDA Guidance for Industry: Exposure–response relationships—study design, data analysis, and regulatory applications. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf. Accessed 01 March 2014.
10. Points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (doc. ref. CPMP/EWP/2655/99). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003420.pdf. Accessed 01 March 2014.
11. Guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev2). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003417.pdf. Accessed 01 March 2014.
12. Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK Jr., Sullivan JE, et al. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother. 2008;52(11):4043–9.
13. Watt K, Benjamin DK Jr., Cohen-Wolkowiez M. Pharmacokinetics of antifungal agents in children. Early Hum Dev. 2011;87(Suppl 1):S61–5.
14. Roos JF, Kirkpatrick CM, Tett SE, McLachlan AJ, Duffull SB. Development of a sufficient design for estimation of fluconazole pharmacokinetics in people with HIV infection. Br J Clin Pharmacol. 2008;66(4):455–66.
15. Fluconazole product monograph. Omega Laboratories, Montreal (last revised 13 Mar 2007).
16. Dash AK, Elmquist WF. Fluconazole. Anal Profiles Drug Subst Excip. 2001;27:67–113.
17. Debruyne D, Ryckelynck JP. Clinical pharmacokinetics of fluconazole. Clin Pharmacokinet. 1993;24(1):10–27.
18. Yeates RA, Ruhnke M, Pfaff G, Hartmann A, Trautmann M, Sarnow E. The pharmacokinetics of fluconazole after a single intravenous dose in AIDS patients. Br J Clin Pharmacol. 1994;38(1):77–9.
19. Cella M, Knibbe C, Danhof M, Della Pasqua O. What is the right dose for children? Br J Clin Pharmacol. 2010;70(4):597–603.
20. Johnson TN. The problems in scaling adult drug doses to children. Arch Dis Child. 2008;93(3):207–11.
21. Guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indication. Committee for human medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003306.pdf. Accessed 01 March 2014.
22. Mahmood I. Interspecies scaling for the prediction of drug clearance in children: application of maximum lifespan potential and an empirical correction factor. Clin Pharmacokinet. 2010;49(7):479–92.
23. Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48:303–32.
24. Peeters MY, Allegaert K, Blussé van Oud-Alblas HJ, Cella M, Tibboel D, Danhof M, et al. Prediction of propofol clearance in children from an allometric model developed in rats, children and adults versus a 0.75 fixed-exponent allometric model. Clin Pharmacokinet. 2010;49(4):269–75.
25. Rhodin MM, Anderson BJ, Peters AM, Coulthard MG, Wilkins B, Cole M, et al. Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol. 2009;24(1):67–76.
26. Rostami-Hodjegan A, Tucker GT. Simulation and prediction of in vivo drug metabolism in human populations from in vitro data. Nat Rev Drug Discov. 2007;6(2):140–8.
27. 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.
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. Zhao W, Lopez E, Biran V, Durrmeyer X, Fakhoury M, Jacqz-Aigrain E. Vancomycin continuous infusion in neonates: dosing optimisation and therapeutic drug monitoring. Arch Dis Child. 2013;98(6):449–53.
30. van den Anker JN, Schwab M, Kearns GL. Developmental pharmacokinetics. Handb Exp Pharmacol. 2011;205:51–75.
31. Chen N, Aleksa K, Woodland C, Rieder M, Koren G. Ontogeny of drug elimination by the human kidney. Pediatr Nephrol. 2006;21(2):160–8.
32. Piper L, Smith PB, Hornik CP, Cheifetz IM, Barrett JS, Moorthy G, et al. Fluconazole loading dose pharmacokinetics and safety in infants. Pediatr Infect Dis J. 2011;30(5):375–8.
33. De Cock RF, Piana C, Krekels EH, Danhof M, Allegaert K, Knibbe CA. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol. 2011;67(Suppl 1):5–16.
34. Hooker AC, Staatz CE, Karlsson MO. Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res. 2007;24(12):2187–97.
35. Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)—a Perl module for NONMEM related programming. Comput Methods Progr Biomed. 2004;75(2):85–94.
36. Brendel K, Comets E, Laffont C, Laveille C, Mentré F. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res. 2006;23(9):2036–49.
37. Comets E, Brendel K, Mentré F. Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the NPDE add-on package for R. Comput Methods Progr Biomed. 2008;90(2):154–66.
38. Saxén H, Hoppu K, Pohjavuori M. Pharmacokinetics of fluconazole in very low birth weight infants during the first two weeks of life. Clin Pharmacol Ther. 1993;54(3):269–77.
39. Mahmood I, Balian JD. Interspecies scaling: predicting clearance of drugs in humans. Three different approaches. Xenobiotica. 1996;26(9):887–95.
40. Sinha VK, De Buck SS, Fenu LA, Smit JW, Nijsen M, Gilissen RA, et al. Predicting oral clearance in humans: how close can we get with allometry? Clin Pharmacokinet. 2008;47(1):35–45.
41. Sinha VK, Vaarties K, De Buck SS, Fenu LA, Nijsen M, Gilissen RA, et al. Towards a better prediction of peak concentration, volume of distribution and half-life after oral drug administration in man, using allometry. Clin Pharmacokinet. 2011;50(5):307–18.
42. Sacher GA. Relation of lifespan to brain weight and body weight in mammals. In Ciba Foundation Symposium—The lifespan of animals (colloquia on ageing) (eds. wolstenholme GEW, O’Connor M) 1959; pp. 115–141.
43. Ullner PM, Di Nardo A, Goldman JE, Schobel S, Yang H, Engelstad K, et al. Murine Glut-1 transporter haplo insufficiency: postnatal deceleration of brain weight and reactive astrocytosis. Neurobiol Dis. 2009;36(1):60–9.
44. Craig AJ, Ramzan I, Malik R. Pharmacokinetics of fluconazole in cats after intravenous and oral administration. Res Vet Sci. 1994;57(3):372–6.
45. Mallo KM, Harms CA, Lewbart GA, Papich MG. Pharmacokinetics of fluconazole in loggerhead sea turtles (Caretta caretta) after single intravenous and subcutaneous injections, and multiple subcutaneous injections. J Zoo Wildl Med. 2002;33(1):29–35.
46. Gross AS, McLachlan AJ, Minns I, Beal JB, Tett SE. Simultaneous administration of a cocktail of markers to measure renal drug elimination pathways: absence of a pharmacokinetic interaction between fluconazole and sinistrin, p-aminohippuric acid and pindolol. Br J Clin Pharmacol. 2001;51(6):547–55.
47. Mahmood I. Dosing in children: a critical review of the pharmacokinetic allometric scaling and modelling approaches in paediatric drug development and clinical settings. Clin Pharmacokinet. 2014;53(4):327–46.
48. Clancy CJ, Staley B, Nguyen MH. In vitro susceptibility of breakthrough Candida bloodstream isolates correlates with daily and cumulative doses of fluconazole. Antimicrob Agents Chemother. 2006;50(10):3496–8.
49. Clancy CJ, Yu VL, Morris AJ, Snydman DR, Nguyen MH. Fluconazole MIC and the fluconazole dose/MIC ratio correlate with therapeutic response among patients with candidemia. Antimicrob Agents Chemother. 2005;49(8):3171–7.