From pediatric covariate model to semiphysiological function for maturation: Part II?Sensitivity to physiological and physicochemical properties

CPT: Pharmacometrics and Systems Pharmacology

Volumn 1, Issue 1, 2012, Pages

  Krekels, E H J ^a,b   Johnson, T N ^c   Den Hoedt, S M ^a   Rostami Hodjegan, A ^c,d   Danhof, M ^a   Tibboel, D ^b   Knibbe, C A J ^a,b,e  

^a LEIDEN UNIVERSITY   (Netherlands)

^b SOPHIA CHILDREN S HOSPITAL   (Netherlands)

^c CERTARA UK LIMITED   (United Kingdom)

^d UNIVERSITY OF MANCHESTER   (United Kingdom)

^e ST ANTONIUS HOSPITAL   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

MORPHINE; ZIDOVUDINE;

ARTICLE; DRUG CLEARANCE; DRUG GLUCURONIDATION; HUMAN; IN VITRO STUDY; IN VIVO STUDY; KINETICS; LIVER BLOOD FLOW; ONTOGENY; PHARMACOLOGICAL PARAMETERS; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; SENSITIVITY ANALYSIS;

EID: 84879802713     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2012.12     Document Type: Article

References (31)

1. Cuzzolin, L., Atzei, A. & Fanos, V. Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety. Expert Opin. Drug Saf. 5, 703-718 (2006
2. Alcorn, J. & McNamara, P.J. Ontogeny of hepatic and renal systemic clearance pathways in infants: Part I. Clin. Pharmacokinet. 41, 959-998 (2002
3. Krekels, E.H.J., Danhof, M., Tibboel, D. & Knibbe, C.A.J. Ontogeny of hepatic glucuronidation; methods and results. Curr Drug Metab. 13, 728-43 (2012
4. Knibbe, C.A., Krekels, E.H. & Danhof, M. Advances in paediatric pharmacokinetics. Expert Opin. Drug Metab. Toxicol. 7, 1-8 (2011
5. Court, M.H. et al. Evaluation of 3'-azido-3'-deoxythymidine, morphine, and codeine as probe substrates for UDP-glucuronosyltransferase 2B7 (UGT2B7) in human liver microsomes: Specificity and influence of the UGT2B7.*2 polymorphism. Drug Metab. Dispos. 31, 1125-1133 (2003)
6. Coffman, B.L., Rios, G.R., King, C.D. & Tephly, T.R. Human UGT2B7 catalyzes morphine glucuronidation. Drug Metab. Dispos. 25, 1-4 (1997
7. Barbier, O. et al. 3'-azido-3'-deoxythimidine (AZT) is glucuronidated by human UDPglucuronosyltransferase 2B7 (UGT2B7). Drug Metab. Dispos. 28, 497-502 (2000
8. Boucher, F.D. et al. Phase I evaluation of zidovudine administered to infants exposed at birth to the human immunodeficiency virus. J. Pediatr. 122, 137-144 (1993
9. Knibbe, C.A. et al. Morphine glucuronidation in preterm neonates, infants and children younger than 3 years. Clin. Pharmacokinet. 48, 371-385 (2009
10. Krekels, E.H. 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. 50, 51-63 (2011
11. Danhof, M., de Jongh, J., De Lange, E.C., Della Pasqua, O., Ploeger, B.A. & Voskuyl, R.A. Mechanism-based pharmacokinetic-pharmacodynamic modeling: Biophase distribution, receptor theory, and dynamical systems analysis. Annu. Rev. Pharmacol. Toxicol. 47, 357-400 (2007
12. De Cock, R.F.W. et al. Maturation of GFR in preterm and term neonates reflected by clearance of different antibiotics. PAGE Abstr 2096, 20 (2011
13. Kearns, G.L., Abdel-Rahman, S.M., Alander, S.W., Blowey, D.L., Leeder, J.S. & Kauffman, R.E. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N. Engl. J. Med. 349, 1157-1167 (2003
14. Manevski, N., Moreolo, P.S., Yli-Kauhaluoma, J. & Finel, M. Bovine serum albumin decreases Km values of human UDP-glucuronosyltransferases 1A9 and 2B7 and increases Vmax values of UGT1A9. Drug Metab. Dispos. 39, 2117-2129 (2011
15. Rowland, A., Gaganis, P., Elliot, D.J., Mackenzie, P.I., Knights, K.M. & Miners, J.O. Binding of inhibitory fatty acids is responsible for the enhancement of UDP-glucuronosyltransferase 2B7 activity by albumin: Implications for in vitro-in vivo extrapolation. J. Pharmacol. Exp. Ther. 321, 137-147 (2007
16. Cella, M., Zhao, W., Jacqz-Aigrain, E., Burger, D., Danhof, M. & Della Pasqua, O. Paediatric drug development: Are population models predictive of pharmacokinetics across paediatric populations? Br. J. Clin. Pharmacol. 72, 454-464 (2011
17. Kaufman, J.J., Semo, N.M. & Koski, W.S. Microelectrometric titration measurement of the pKa's and partition and drug distribution coefficients of narcotics and narcotic antagonists and their pH and temperature dependence. J. Med. Chem. 18, 647-655 (1975
18. Acosta, E.P., Page, L.M. & Fletcher, C.V. Clinical pharmacokinetics of zidovudine. An update. Clin. Pharmacokinet. 30, 251-262 (1996
19. Uchaipichat, V., Winner, L.K., Mackenzie, P.I., Elliot, D.J., Williams, J.A. & Miners, J.O. Quantitative prediction of in vivo inhibitory interactions involving glucuronidated drugs from in vitro data: The effect of fluconazole on zidovudine glucuronidation. Br. J. Clin. Pharmacol. 61, 427-439 (2006
20. Luzier, A. & Morse, G.D. Intravascular distribution of zidovudine: Role of plasma proteins and whole blood components. Antiviral Res. 21, 267-280 (1993
21. Teijeiro, S.A., Moroni, G., Motura, M. & Brinon, M.C. Lipophilic character of pyrimidinic nucleoside derivatives: Correlation between shake flask, chromatographic (RP-TLC and RP-HPLC) and theoretical methods. J. Liq. Chrom. & Rel. Technol. 23, 855-872 (2000
22. Olsen, G.D. Morphine binding to human plasma proteins. Clin. Pharmacol. Ther. 17, 31-35 (1975
23. Quevedo, M.A., Ribone, S.R., Moroni, G.N. & Briñón, M.C. Binding to human serum albumin of zidovudine (AZT) and novel AZT derivatives. Experimental and theoretical analyses. Bioorg. Med. Chem. 16, 2779-2790 (2008
24. Stanski, D.R., Greenblatt, D.J. & Lowenstein, E. Kinetics of intravenous and intramuscular morphine. Clin. Pharmacol. Ther. 24, 52-59 (1978
25. Crotty, B. et al. Hepatic extraction of morphine is impaired in cirrhosis. Eur. J. Clin. Pharmacol. 36, 501-506 (1989
26. Naritomi, Y., Terashita, S., Kagayama, A. & Sugiyama, Y. Utility of hepatocytes in predicting drug metabolism: Comparison of hepatic intrinsic clearance in rats and humans in vivo and in vitro. Drug Metab. Dispos. 31, 580-588 (2003
27. Krekels, E.H.J. et al. From pediatric covariate model to semiphysiological function for maturation: Part II - sensitivity to physiological and physicochemical properties. CPT Pharmacomet Syst. Pharmacol. 1, eXX (2012
28. Krekels, E.H., van Hasselt, J.G., Tibboel, D., Danhof, M. & Knibbe, C.A. Systematic evaluation of the descriptive and predictive performance of paediatric morphine population models. Pharm. Res. 28, 797-811 (2011
29. Fisher, D.M. PLT Tools. (2011
30. 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. 23, 2036-2049 (2006
31. 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 Programs Biomed. 90, 154-166 (2008