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Volumn 38, Issue 1, 2011, Pages 25-40

Pharmacokinetic design optimization in children and estimation of maturation parameters: Example of cytochrome P450 3A4

Author keywords

Children; Maturation function; Population pharmacokinetics; Protocol optimisation

Indexed keywords

CYTOCHROME P450 3A4; MIDAZOLAM;

EID: 79551596429     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-010-9173-1     Document Type: Article
Times cited : (17)

References (37)
  • 1
    • 0141857724 scopus 로고    scopus 로고
    • Developmental pharmacology-drug disposition, action, and therapy in infants and children
    • 1:CAS:528:DC%2BD3sXnsV2jtbo%3D 10.1056/NEJMra035092 13679531
    • GL Kearns SM Abdel-Rahman SW Alander DL Blowey JS Leeder RE Kauffman 2003 Developmental pharmacology-drug disposition, action, and therapy in infants and children N Engl J Med 349 1157 1167 1:CAS:528:DC%2BD3sXnsV2jtbo%3D 10.1056/NEJMra035092 13679531
    • (2003) N Engl J Med , vol.349 , pp. 1157-1167
    • Kearns, G.L.1    Abdel-Rahman, S.M.2    Alander, S.W.3    Blowey, D.L.4    Leeder, J.S.5    Kauffman, R.E.6
  • 2
    • 33645299020 scopus 로고    scopus 로고
    • Age and size are the major covariates for prediction of levobupivacaine clearance in children
    • 10.1111/j.1460-9592.2005.01778.x 16490091
    • GA Chalkiadis BJ Anderson 2006 Age and size are the major covariates for prediction of levobupivacaine clearance in children Paediatr Anaesth 16 275 282 10.1111/j.1460-9592.2005.01778.x 16490091
    • (2006) Paediatr Anaesth , vol.16 , pp. 275-282
    • Chalkiadis, G.A.1    Anderson, B.J.2
  • 3
    • 31344444671 scopus 로고    scopus 로고
    • Prediction of cytochrome p450-mediated hepatic drug clearance in neonates, infants and children: How accurate are available scaling methods?
    • 10.2165/00003088-200645010-00001 16430308
    • S Bjorkman 2006 Prediction of cytochrome p450-mediated hepatic drug clearance in neonates, infants and children : how accurate are available scaling methods? Clin Pharmacokinet 45 1 11 10.2165/00003088-200645010-00001 16430308
    • (2006) Clin Pharmacokinet , vol.45 , pp. 1-11
    • Bjorkman, S.1
  • 4
    • 33745584148 scopus 로고    scopus 로고
    • Development and evaluation of a generic physiologically based pharmacokinetic model for children
    • 1:CAS:528:DC%2BD28XhtF2rurzP 10.2165/00003088-200645100-00005 16984214
    • AN Edginton W Schmitt S Willmann 2006 Development and evaluation of a generic physiologically based pharmacokinetic model for children Clin Pharmacokinet 45 1013 1034 1:CAS:528:DC%2BD28XhtF2rurzP 10.2165/00003088- 200645100-00005 16984214
    • (2006) Clin Pharmacokinet , vol.45 , pp. 1013-1034
    • Edginton, A.N.1    Schmitt, W.2    Willmann, S.3
  • 5
    • 33745599327 scopus 로고    scopus 로고
    • A mechanistic approach for the scaling of clearance in children
    • 1:CAS:528:DC%2BD28Xot1eksLs%3D 10.2165/00003088-200645070-00004 16802850
    • AN Edginton W Schmitt B Voith S Willmann 2006 A mechanistic approach for the scaling of clearance in children Clin Pharmacokinet 45 683 704 1:CAS:528:DC%2BD28Xot1eksLs%3D 10.2165/00003088-200645070-00004 16802850
    • (2006) Clin Pharmacokinet , vol.45 , pp. 683-704
    • Edginton, A.N.1    Schmitt, W.2    Voith, B.3    Willmann, S.4
  • 6
    • 41149180911 scopus 로고    scopus 로고
    • Mechanism-based concepts of size and maturity in pharmacokinetics
    • 1:CAS:528:DC%2BD1cXisFynu7g%3D 10.1146/annurev.pharmtox.48.113006.094708 17914927
    • BJ Anderson NH Holford 2008 Mechanism-based concepts of size and maturity in pharmacokinetics Annu Rev Pharmacol Toxicol 48 303 332 1:CAS:528: DC%2BD1cXisFynu7g%3D 10.1146/annurev.pharmtox.48.113006.094708 17914927
    • (2008) Annu Rev Pharmacol Toxicol , vol.48 , pp. 303-332
    • Anderson, B.J.1    Holford, N.H.2
  • 7
    • 33746803672 scopus 로고    scopus 로고
    • Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children
    • 1:CAS:528:DC%2BD28XhtVGisrvN 10.2165/00003088-200645090-00005 16928154
    • TN Johnson A Rostami-Hodjegan GT Tucker 2006 Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children Clin Pharmacokinet 45 931 956 1:CAS:528:DC%2BD28XhtVGisrvN 10.2165/00003088- 200645090-00005 16928154
    • (2006) Clin Pharmacokinet , vol.45 , pp. 931-956
    • Johnson, T.N.1    Rostami-Hodjegan, A.2    Tucker, G.T.3
  • 9
    • 40549143738 scopus 로고    scopus 로고
    • Facilitation of drug evaluation in children by population methods and modelling
    • 1:CAS:528:DC%2BD1cXltl2ntLg%3D 10.2165/00003088-200847040-00002 18336053
    • M Tod V Jullien G Pons 2008 Facilitation of drug evaluation in children by population methods and modelling Clin Pharmacokinet 47 231 243 1:CAS:528:DC%2BD1cXltl2ntLg%3D 10.2165/00003088-200847040-00002 18336053
    • (2008) Clin Pharmacokinet , vol.47 , pp. 231-243
    • Tod, M.1    Jullien, V.2    Pons, G.3
  • 10
    • 33750344295 scopus 로고    scopus 로고
    • Population clinical pharmacology of children: Modelling covariate effects
    • 10.1007/s00431-006-0189-x 16807729
    • BJ Anderson K Allegaert NH Holford 2006 Population clinical pharmacology of children: modelling covariate effects Eur J Pediatr 165 819 829 10.1007/s00431-006-0189-x 16807729
    • (2006) Eur J Pediatr , vol.165 , pp. 819-829
    • Anderson, B.J.1    Allegaert, K.2    Holford, N.H.3
  • 11
    • 33947143568 scopus 로고    scopus 로고
    • A program for individual and population optimal design for univariate and multivariate response pharmacokinetic-pharmacodynamic models
    • 10.1016/j.cmpb.2007.01.004 17292995
    • I Gueorguieva K Ogungbenro G Graham S Glatt L Aarons 2007 A program for individual and population optimal design for univariate and multivariate response pharmacokinetic-pharmacodynamic models Comput Methods Programs Biomed 86 51 61 10.1016/j.cmpb.2007.01.004 17292995
    • (2007) Comput Methods Programs Biomed , vol.86 , pp. 51-61
    • Gueorguieva, I.1    Ogungbenro, K.2    Graham, G.3    Glatt, S.4    Aarons, L.5
  • 12
    • 33947277872 scopus 로고    scopus 로고
    • A d-optimal designed population pharmacokinetic study of oral itraconazole in adult cystic fibrosis patients
    • 1:CAS:528:DC%2BD2sXlt1ahurw%3D 10.1111/j.1365-2125.2006.02778.x 17073891
    • S Hennig TH Waterhouse SC Bell, et al. 2007 A d-optimal designed population pharmacokinetic study of oral itraconazole in adult cystic fibrosis patients Br J Clin Pharmacol 63 438 450 1:CAS:528:DC%2BD2sXlt1ahurw%3D 10.1111/j.1365-2125.2006.02778.x 17073891
    • (2007) Br J Clin Pharmacol , vol.63 , pp. 438-450
    • Hennig, S.1    Waterhouse, T.H.2    Bell, S.C.3
  • 13
    • 85083125159 scopus 로고    scopus 로고
    • Université Paris 7, Paris, France. PFIM 3.0
    • Bazzoli C, Retout S, Comets E and Mentré F (2008) INSERM U, Université Paris 7, Paris, France. PFIM 3.0. Available at: http://www.pfim.biostat.fr/Read-me-PFIM3.0.pdf
    • (2008) INSERM U
    • Bazzoli C, R.1
  • 14
    • 77950369264 scopus 로고    scopus 로고
    • Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0
    • Bazzoli C, Retout S, Mentré F (2009) Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0. Comput Methods Programs Biomed 98(1):55-65
    • (2009) Comput Methods Programs Biomed , vol.98 , Issue.1 , pp. 55-65
    • Bazzoli C, R.1
  • 15
    • 0000963178 scopus 로고    scopus 로고
    • Optimal design in random-effects regression models
    • 10.1093/biomet/84.2.429
    • F Mentre F A Mallet D Baccar 1997 Optimal design in random-effects regression models Biometrika 84 429 442 10.1093/biomet/84.2.429
    • (1997) Biometrika , vol.84 , pp. 429-442
    • Mentre, F.F.1    Mallet, A.2    Baccar, D.3
  • 16
    • 36349024782 scopus 로고    scopus 로고
    • Design in nonlinear mixed effects models: Optimization using the Fedorov-Wynn algorithm and power of the Wald test for binary covariates
    • 10.1002/sim.2910 17486667
    • S Retout E Comets A Samson F Mentre 2007 Design in nonlinear mixed effects models: optimization using the Fedorov-Wynn algorithm and power of the Wald test for binary covariates Stat Med 26 5162 5179 10.1002/sim.2910 17486667
    • (2007) Stat Med , vol.26 , pp. 5162-5179
    • Retout, S.1    Comets, E.2    Samson, A.3    Mentre, F.4
  • 17
    • 1242269754 scopus 로고    scopus 로고
    • Optimization of individual and population designs using Splus
    • 10.1023/B:JOPA.0000013000.59346.9a 15000423
    • S Retout F Mentre 2003 Optimization of individual and population designs using Splus J Pharmacokinet Pharmacodyn 30 417 443 10.1023/B:JOPA.0000013000. 59346.9a 15000423
    • (2003) J Pharmacokinet Pharmacodyn , vol.30 , pp. 417-443
    • Retout, S.1    Mentre, F.2
  • 19
    • 0024509738 scopus 로고
    • Pharmacokinetics of midazolam following intravenous and oral administration in patients with chronic liver disease and in healthy subjects
    • 1:STN:280:DyaL1M3ls1Smuw%3D%3D 2723115
    • PJ Pentikainen L Valisalmi JJ Himberg C Crevoisier 1989 Pharmacokinetics of midazolam following intravenous and oral administration in patients with chronic liver disease and in healthy subjects J Clin Pharmacol 29 272 277 1:STN:280:DyaL1M3ls1Smuw%3D%3D 2723115
    • (1989) J Clin Pharmacol , vol.29 , pp. 272-277
    • Pentikainen, P.J.1    Valisalmi, L.2    Himberg, J.J.3    Crevoisier, C.4
  • 20
    • 0020518360 scopus 로고
    • CSF penetration and pharmacokinetics of midazolam
    • 1:STN:280:DyaL2c%2FivVyhtQ%3D%3D 10.1007/BF00543799 6628509
    • S Sjovall J Kanto JJ Himberg M Hovi-Viander M Salo 1983 CSF penetration and pharmacokinetics of midazolam Eur J Clin Pharmacol 25 247 251 1:STN:280:DyaL2c%2FivVyhtQ%3D%3D 10.1007/BF00543799 6628509
    • (1983) Eur J Clin Pharmacol , vol.25 , pp. 247-251
    • Sjovall, S.1    Kanto, J.2    Himberg, J.J.3    Hovi-Viander, M.4    Salo, M.5
  • 21
    • 65549128284 scopus 로고    scopus 로고
    • Population pharmacokinetics of levetiracetam and dosing recommendation in children with epilepsy
    • 1:CAS:528:DC%2BD1MXms1Skt7w%3D 10.1111/j.1528-1167.2008.01974.x 19175400
    • S Chhun V Jullien E Rey O Dulac C Chiron G Pons 2009 Population pharmacokinetics of levetiracetam and dosing recommendation in children with epilepsy Epilepsia 50 1150 1157 1:CAS:528:DC%2BD1MXms1Skt7w%3D 10.1111/j.1528-1167.2008.01974.x 19175400
    • (2009) Epilepsia , vol.50 , pp. 1150-1157
    • Chhun, S.1    Jullien, V.2    Rey, E.3    Dulac, O.4    Chiron, C.5    Pons, G.6
  • 22
    • 0345374663 scopus 로고    scopus 로고
    • Population pharmacokinetic modelling of darifenacin and its hydroxylated metabolite using pooled data, incorporating saturable first-pass metabolism, CYP2D6 genotype and formulation-dependent bioavailability
    • 1:CAS:528:DC%2BD2cXivFSmsw%3D%3D 10.1046/j.1365-2125.2003.01967.x 14616424
    • T Kerbusch U Wahlby PA Milligan MO Karlsson 2003 Population pharmacokinetic modelling of darifenacin and its hydroxylated metabolite using pooled data, incorporating saturable first-pass metabolism, CYP2D6 genotype and formulation-dependent bioavailability Br J Clin Pharmacol 56 639 652 1:CAS:528:DC%2BD2cXivFSmsw%3D%3D 10.1046/j.1365-2125.2003.01967.x 14616424
    • (2003) Br J Clin Pharmacol , vol.56 , pp. 639-652
    • Kerbusch, T.1    Wahlby, U.2    Milligan, P.A.3    Karlsson, M.O.4
  • 23
    • 33751335379 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of midazolam and metabolites in nonventilated infants after craniofacial surgery
    • 1:CAS:528:DC%2BD28Xht1CgtLvN 10.1097/00000542-200612000-00013 17122576
    • MY Peeters SA Prins CA Knibbe, et al. 2006 Pharmacokinetics and pharmacodynamics of midazolam and metabolites in nonventilated infants after craniofacial surgery Anesthesiology 105 1135 1146 1:CAS:528:DC%2BD28Xht1CgtLvN 10.1097/00000542-200612000-00013 17122576
    • (2006) Anesthesiology , vol.105 , pp. 1135-1146
    • Peeters, M.Y.1    Prins, S.A.2    Knibbe, C.A.3
  • 24
    • 0042344946 scopus 로고    scopus 로고
    • Pharmacokinetics of midazolam in neonates undergoing extracorporeal membrane oxygenation
    • 1:CAS:528:DC%2BD3sXlvVSgsLg%3D 10.1097/00000542-200308000-00008 12883399
    • H Mulla P McCormack G Lawson RK Firmin DR Upton 2003 Pharmacokinetics of midazolam in neonates undergoing extracorporeal membrane oxygenation Anesthesiology 99 275 282 1:CAS:528:DC%2BD3sXlvVSgsLg%3D 10.1097/00000542- 200308000-00008 12883399
    • (2003) Anesthesiology , vol.99 , pp. 275-282
    • Mulla, H.1    McCormack, P.2    Lawson, G.3    Firmin, R.K.4    Upton, D.R.5
  • 26
    • 0019604592 scopus 로고
    • Some suggestions for measuring predictive performance
    • 1:STN:280:DyaL38%2FnslGruw%3D%3D 10.1007/BF01060893 7310648
    • LB Sheiner SL Beal 1981 Some suggestions for measuring predictive performance J Pharmacokinet Biopharm 9 503 512 1:STN:280:DyaL38%2FnslGruw%3D%3D 10.1007/BF01060893 7310648
    • (1981) J Pharmacokinet Biopharm , vol.9 , pp. 503-512
    • Sheiner, L.B.1    Beal, S.L.2
  • 27
    • 33947259323 scopus 로고    scopus 로고
    • Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004
    • 10.2165/00003088-200746030-00003 17328581
    • K Brendel C Dartois E Comets, et al. 2007 Are population pharmacokinetic and/or pharmacodynamic models adequately evaluated? A survey of the literature from 2002 to 2004 Clin Pharmacokinet 46 221 234 10.2165/00003088-200746030-00003 17328581
    • (2007) Clin Pharmacokinet , vol.46 , pp. 221-234
    • Brendel, K.1    Dartois, C.2    Comets, E.3
  • 28
    • 0038336553 scopus 로고    scopus 로고
    • Prospective evaluation of a D-optimal designed population pharmacokinetic study
    • 1:CAS:528:DC%2BD3sXms1yhtLs%3D 10.1023/A:1024467714170 12942685
    • B Green SB Duffull 2003 Prospective evaluation of a D-optimal designed population pharmacokinetic study J Pharmacokinet Pharmacodyn 30 145 161 1:CAS:528:DC%2BD3sXms1yhtLs%3D 10.1023/A:1024467714170 12942685
    • (2003) J Pharmacokinet Pharmacodyn , vol.30 , pp. 145-161
    • Green, B.1    Duffull, S.B.2
  • 29
    • 0038271984 scopus 로고    scopus 로고
    • Optimal sampling strategies to assess inulin clearance in children by the inulin single-injection method
    • 10.1373/49.7.1170 12816915
    • LK van Rossum RA Mathot K Cransberg AG Vulto 2003 Optimal sampling strategies to assess inulin clearance in children by the inulin single-injection method Clin Chem 49 1170 1179 10.1373/49.7.1170 12816915
    • (2003) Clin Chem , vol.49 , pp. 1170-1179
    • Van Rossum, L.K.1    Mathot, R.A.2    Cransberg, K.3    Vulto, A.G.4
  • 30
    • 30644471976 scopus 로고    scopus 로고
    • Development and validation of limited sampling models for topotecan lactone pharmacokinetic studies in children
    • 1:CAS:528:DC%2BD28XjtVyiuw%3D%3D 10.1007/s00280-005-0062-z 16047146
    • PK Turner LC Iacono JC Panetta, et al. 2006 Development and validation of limited sampling models for topotecan lactone pharmacokinetic studies in children Cancer Chemother Pharmacol 57 475 482 1:CAS:528:DC%2BD28XjtVyiuw%3D%3D 10.1007/s00280-005-0062-z 16047146
    • (2006) Cancer Chemother Pharmacol , vol.57 , pp. 475-482
    • Turner, P.K.1    Iacono, L.C.2    Panetta, J.C.3
  • 31
    • 33845453628 scopus 로고    scopus 로고
    • Vancomycin pharmacokinetics in preterm neonates and the prediction of adult clearance
    • 1:CAS:528:DC%2BD2sXhsFWqu78%3D 10.1111/j.1365-2125.2006.02725.x 16869817
    • BJ Anderson K Allegaert JN Van den Anker V Cossey NH Holford 2007 Vancomycin pharmacokinetics in preterm neonates and the prediction of adult clearance Br J Clin Pharmacol 63 75 84 1:CAS:528:DC%2BD2sXhsFWqu78%3D 10.1111/j.1365-2125.2006.02725.x 16869817
    • (2007) Br J Clin Pharmacol , vol.63 , pp. 75-84
    • Anderson, B.J.1    Allegaert, K.2    Van Den Anker, J.N.3    Cossey, V.4    Holford, N.H.5
  • 32
    • 0035170198 scopus 로고    scopus 로고
    • Pharmacokinetics of oral acyclovir in neonates and in infants: A population analysis
    • 1:CAS:528:DC%2BD3MXhsFGjug%3D%3D 10.1128/AAC.45.1.150-157.2001 11120958
    • M Tod F Lokiec R Bidault F De Bony O Petitjean Y Aujard 2001 Pharmacokinetics of oral acyclovir in neonates and in infants: a population analysis Antimicrob Agents Chemother 45 150 157 1:CAS:528:DC%2BD3MXhsFGjug%3D%3D 10.1128/AAC.45.1.150-157.2001 11120958
    • (2001) Antimicrob Agents Chemother , vol.45 , pp. 150-157
    • Tod, M.1    Lokiec, F.2    Bidault, R.3    De Bony, F.4    Petitjean, O.5    Aujard, Y.6
  • 33
    • 0028234586 scopus 로고
    • Regioselective biotransformation of midazolam by members of the human cytochrome P450 3A (CYP3A) subfamily
    • 1:CAS:528:DyaK2cXksV2mtLg%3D 10.1016/0006-2952(94)90543-6 8185679
    • JC Gorski SD Hall DR Jones M VandenBranden SA Wrighton 1994 Regioselective biotransformation of midazolam by members of the human cytochrome P450 3A (CYP3A) subfamily Biochem Pharmacol 47 1643 1653 1:CAS:528: DyaK2cXksV2mtLg%3D 10.1016/0006-2952(94)90543-6 8185679
    • (1994) Biochem Pharmacol , vol.47 , pp. 1643-1653
    • Gorski, J.C.1    Hall, S.D.2    Jones, D.R.3    Vandenbranden, M.4    Wrighton, S.A.5
  • 34
    • 3142741726 scopus 로고    scopus 로고
    • Pharmacokinetics of midazolam in CYP3A4- and CYP3A5-genotyped subjects
    • 1:CAS:528:DC%2BD2cXltVKmt7Y%3D 15114431
    • CB Eap T Buclin E Hustert, et al. 2004 Pharmacokinetics of midazolam in CYP3A4- and CYP3A5-genotyped subjects Eur J Clin Pharmacol 60 231 236 1:CAS:528:DC%2BD2cXltVKmt7Y%3D 15114431
    • (2004) Eur J Clin Pharmacol , vol.60 , pp. 231-236
    • Eap, C.B.1    Buclin, T.2    Hustert, E.3
  • 35
    • 27144556111 scopus 로고    scopus 로고
    • Effect of common CYP3A4 and CYP3A5 variants on the pharmacokinetics of the cytochrome P450 3A phenotyping probe midazolam in cancer patients
    • 1:CAS:528:DC%2BD2MXhtFartbvM 10.1158/1078-0432.CCR-05-0520 16243813
    • ER Lepper SD Baker M Permenter, et al. 2005 Effect of common CYP3A4 and CYP3A5 variants on the pharmacokinetics of the cytochrome P450 3A phenotyping probe midazolam in cancer patients Clin Cancer Res 11 7398 7404 1:CAS:528:DC%2BD2MXhtFartbvM 10.1158/1078-0432.CCR-05-0520 16243813
    • (2005) Clin Cancer Res , vol.11 , pp. 7398-7404
    • Lepper, E.R.1    Baker, S.D.2    Permenter, M.3
  • 36
    • 64149107347 scopus 로고    scopus 로고
    • Drug-drug interaction predictions with PBPK models and optimal multiresponse sampling time designs: Application to midazolam and a phase i compound. Part 1: Comparison of uniresponse and multiresponse designs using PopDes
    • 1:CAS:528:DC%2BD1MXpvVeluw%3D%3D 10.1007/s10928-008-9104-6 19130188
    • M Chenel F Bouzom L Aarons K Ogungbenro 2008 Drug-drug interaction predictions with PBPK models and optimal multiresponse sampling time designs: application to midazolam and a phase I compound. Part 1: comparison of uniresponse and multiresponse designs using PopDes J Pharmacokinet Pharmacodyn 35 635 659 1:CAS:528:DC%2BD1MXpvVeluw%3D%3D 10.1007/s10928-008-9104-6 19130188
    • (2008) J Pharmacokinet Pharmacodyn , vol.35 , pp. 635-659
    • Chenel, M.1    Bouzom, F.2    Aarons, L.3    Ogungbenro, K.4
  • 37
    • 63849225944 scopus 로고    scopus 로고
    • In vitro and in vivo glucuronidation of midazolam in humans
    • 1:CAS:528:DC%2BD1MXlvFSju78%3D 10.1111/j.1365-2125.2009.03386.x 19371318
    • R Hyland T Osborne A Payne, et al. 2009 In vitro and in vivo glucuronidation of midazolam in humans Br J Clin Pharmacol 67 445 454 1:CAS:528:DC%2BD1MXlvFSju78%3D 10.1111/j.1365-2125.2009.03386.x 19371318
    • (2009) Br J Clin Pharmacol , vol.67 , pp. 445-454
    • Hyland, R.1    Osborne, T.2    Payne, A.3


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