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Volumn 92, Issue 1, 2012, Pages 40-49

Physiologically Based Pharmacokinetic (PBPK) modeling in children

Author keywords

[No Author keywords available]

Indexed keywords

DRUG DEVELOPMENT; HUMAN; MODEL; NONHUMAN; PHARMACODYNAMICS; PHARMACOKINETICS; PHYSIOLOGICALLY BASED PHARMACOKINETIC; PRIORITY JOURNAL; REVIEW;

EID: 84862617981     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2012.64     Document Type: Review
Times cited : (162)

References (75)
  • 2
    • 41749105125 scopus 로고    scopus 로고
    • The problems in scaling adult drug doses to children
    • Johnson, T.N. The problems in scaling adult drug doses to children. Arch. Dis. Child. 93, 207-211 (2008).
    • (2008) Arch. Dis. Child. , vol.93 , pp. 207-211
    • Johnson, T.N.1
  • 4
    • 0031011257 scopus 로고    scopus 로고
    • Calculation of drug dosage and body surface area of children
    • Lack, J.A. & Stuart-Taylor, M.E. Calculation of drug dosage and body surface area of children. Br. J. Anaesth. 78, 601-605 (1997).
    • (1997) Br. J. Anaesth. , vol.78 , pp. 601-605
    • Lack, J.A.1    Stuart-Taylor, M.E.2
  • 6
    • 70349271378 scopus 로고    scopus 로고
    • The in silico child: Using simulation to guide pediatric drug development and manage pediatric pharmacotherapy
    • Läer, S., Barrett, J.S. & Meibohm, B. The in silico child: using simulation to guide pediatric drug development and manage pediatric pharmacotherapy. J. Clin. Pharmacol. 49, 889-904 (2009).
    • (2009) J. Clin. Pharmacol. , vol.49 , pp. 889-904
    • Läer, S.1    Barrett, J.S.2    Meibohm, B.3
  • 7
    • 79955580428 scopus 로고    scopus 로고
    • Modelling and simulation as research tools in paediatric drug development
    • Bellanti, F. & Della Pasqua, O. Modelling and simulation as research tools in paediatric drug development. Eur. J. Clin. Pharmacol. 67 (suppl. 1), 75-86 (2011).
    • (2011) Eur. J. Clin. Pharmacol. , vol.67 , Issue.SUPPL. 1 , pp. 75-86
    • Bellanti, F.1    Della Pasqua, O.2
  • 8
    • 70449105165 scopus 로고    scopus 로고
    • Proposals for model-based paediatric medicinal development within the current European Union regulatory framework
    • Manolis, E. & Pons, G. Proposals for model-based paediatric medicinal development within the current European Union regulatory framework. Br. J. Clin. Pharmacol. 68, 493-501 (2009).
    • (2009) Br. J. Clin. Pharmacol. , vol.68 , pp. 493-501
    • Manolis, E.1    Pons, G.2
  • 9
    • 78449301742 scopus 로고    scopus 로고
    • The need for modeling and simulation to design clinical investigations in children
    • Jadhav, P.R. & Kern, S.E. The need for modeling and simulation to design clinical investigations in children. J. Clin. Pharmacol. 50, 121S-129S (2010).
    • (2010) J. Clin. Pharmacol. , vol.50
    • Jadhav, P.R.1    Kern, S.E.2
  • 10
    • 79951650070 scopus 로고    scopus 로고
    • Role of modeling and simulation in pediatric investigation plans
    • Manolis, E. et al. Role of modeling and simulation in pediatric investigation plans. Paediatr. Anaesth. 21, 214-221 (2011).
    • (2011) Paediatr. Anaesth. , vol.21 , pp. 214-221
    • Manolis, E.1
  • 11
    • 20644465189 scopus 로고    scopus 로고
    • Prediction of drug disposition in infants and children by means of physiologically based pharmacokinetic (PBPK) modelling: Theophylline and midazolam as model drugs
    • Björkman, 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. 59, 691-704 (2005).
    • (2005) Br. J. Clin. Pharmacol. , vol.59 , pp. 691-704
    • Björkman, S.1
  • 12
    • 70450257804 scopus 로고    scopus 로고
    • Clinical trial simulations in pediatric patients using realistic covariates: Application to teduglutide, a glucagon-like peptide-2 analog in neonates and infants with short-bowel syndrome
    • Mouksassi, M.S., Marier, J.F., Cyran, J. & Vinks, A.A. Clinical trial simulations in pediatric patients using realistic covariates: application to teduglutide, a glucagon-like peptide-2 analog in neonates and infants with short-bowel syndrome. Clin. Pharmacol. Ther. 86, 667-671 (2009).
    • (2009) Clin. Pharmacol. Ther. , vol.86 , pp. 667-671
    • Mouksassi, M.S.1    Marier, J.F.2    Cyran, J.3    Vinks, A.A.4
  • 13
    • 30444448534 scopus 로고    scopus 로고
    • Population pharmacokinetic studies in pediatrics: Issues in design and analysis
    • Meibohm, B., Läer, S., Panetta, J.C. & Barrett, J.S. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 7, E475-E487 (2005).
    • (2005) AAPS J. , vol.7
    • Meibohm, B.1    Läer, S.2    Panetta, J.C.3    Barrett, J.S.4
  • 14
    • 27744432403 scopus 로고    scopus 로고
    • Development of a safe and effective pediatric dosing regimen for sotalol based on population pharmacokinetics and pharmacodynamics in children with supraventricular tachycardia
    • Läer, S. et al. Development of a safe and effective pediatric dosing regimen for sotalol based on population pharmacokinetics and pharmacodynamics in children with supraventricular tachycardia. J. Am. Coll. Cardiol. 46, 1322-1330 (2005).
    • (2005) J. Am. Coll. Cardiol. , vol.46 , pp. 1322-1330
    • Läer, S.1
  • 15
    • 80052262709 scopus 로고    scopus 로고
    • 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
    • Poulin, P. 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. 100, 4127-4157 (2011).
    • (2011) J. Pharm. Sci. , vol.100 , pp. 4127-4157
    • Poulin, P.1
  • 16
    • 79951765993 scopus 로고    scopus 로고
    • Physiologically-based pharmacokinetics in drug development and regulatory science
    • Rowland, M., Peck, C. & Tucker, G. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu. Rev. Pharmacol. Toxicol. 51, 45-73 (2011).
    • (2011) Annu. Rev. Pharmacol. Toxicol. , vol.51 , pp. 45-73
    • Rowland, M.1    Peck, C.2    Tucker, G.3
  • 17
    • 33745599327 scopus 로고    scopus 로고
    • A mechanistic approach for the scaling of clearance in children
    • Edginton, A.N., Schmitt, W., Voith, B. & Willmann, S. A mechanistic approach for the scaling of clearance in children. Clin. Pharmacokinet. 45, 683-704 (2006).
    • (2006) Clin. Pharmacokinet. , vol.45 , pp. 683-704
    • Edginton, A.N.1    Schmitt, W.2    Voith, B.3    Willmann, S.4
  • 18
    • 33750380248 scopus 로고    scopus 로고
    • Guidelines on paediatric dosing on the basis of developmental physiology and pharmacokinetic considerations
    • Bartelink, I.H., Rademaker, C.M., Schobben, A.F. & van den Anker, J.N. Guidelines on paediatric dosing on the basis of developmental physiology and pharmacokinetic considerations. Clin. Pharmacokinet. 45, 1077-1097 (2006).
    • (2006) Clin. Pharmacokinet. , vol.45 , pp. 1077-1097
    • Bartelink, I.H.1    Rademaker, C.M.2    Schobben, A.F.3    Van Den Anker, J.N.4
  • 20
    • 33745584148 scopus 로고    scopus 로고
    • Development and evaluation of a generic physiologically based pharmacokinetic model for children
    • Edginton, A.N., Schmitt, W. & Willmann, S. Development and evaluation of a generic physiologically based pharmacokinetic model for children. Clin. Pharmacokinet. 45, 1013-1034 (2006).
    • (2006) Clin. Pharmacokinet. , vol.45 , pp. 1013-1034
    • Edginton, A.N.1    Schmitt, W.2    Willmann, S.3
  • 21
    • 28244483121 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic modelling: A sound mechanistic basis is needed
    • Aarons, L. Physiologically based pharmacokinetic modelling: a sound mechanistic basis is needed. Br. J. Clin. Pharmacol. 60, 581-583 (2005).
    • (2005) Br. J. Clin. Pharmacol. , vol.60 , pp. 581-583
    • Aarons, L.1
  • 22
    • 35648945837 scopus 로고    scopus 로고
    • On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development
    • Lowe, P.J., Hijazi, Y., Luttringer, O., Yin, H., Sarangapani, R. & Howard, D. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development. Xenobiotica. 37, 1331-1354 (2007).
    • (2007) Xenobiotica. , vol.37 , pp. 1331-1354
    • Lowe, P.J.1    Hijazi, Y.2    Luttringer, O.3    Yin, H.4    Sarangapani, R.5    Howard, D.6
  • 23
    • 67649392513 scopus 로고    scopus 로고
    • A framework for assessing inter-individual variability in pharmacokinetics using virtual human populations and integrating general knowledge of physical chemistry, biology, anatomy, physiology and genetics: A tale of 'bottom-up' vs 'top-down'recognition of covariates
    • Jamei, M., Dickinson, G.L. & Rostami-Hodjegan, A. A framework for assessing inter-individual variability in pharmacokinetics using virtual human populations and integrating general knowledge of physical chemistry, biology, anatomy, physiology and genetics: a tale of 'bottom-up' vs 'top-down'recognition of covariates. Drug Metab. Pharmacokinet. 24, 53-75 (2009).
    • (2009) Drug Metab. Pharmacokinet. , vol.24 , pp. 53-75
    • Jamei, M.1    Dickinson, G.L.2    Rostami-Hodjegan, A.3
  • 24
    • 0036396419 scopus 로고    scopus 로고
    • Ontogeny of hepatic and renal systemic clearance pathways in infants: Part I
    • Alcorn, J. & McNamara, P.J. Ontogeny of hepatic and renal systemic clearance pathways in infants: part I. Clin. Pharmacokinet. 41, 959-998 (2002).
    • (2002) Clin. Pharmacokinet. , vol.41 , pp. 959-998
    • Alcorn, J.1    McNamara, P.J.2
  • 25
    • 33746803672 scopus 로고    scopus 로고
    • Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children
    • Johnson, T.N., Rostami-Hodjegan, A. & Tucker, G.T. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin. Pharmacokinet. 45, 931-956 (2006).
    • (2006) Clin. Pharmacokinet. , vol.45 , pp. 931-956
    • Johnson, T.N.1    Rostami-Hodjegan, A.2    Tucker, G.T.3
  • 27
    • 1042300334 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic (PBPK) modeling of caffeine and theophylline in neonates and adults: Implications for assessing children's risks from environmental agents
    • Ginsberg, G., Hattis, D., Russ, A. & Sonawane, B. Physiologically based pharmacokinetic (PBPK) modeling of caffeine and theophylline in neonates and adults: implications for assessing children's risks from environmental agents. J. Toxicol. Environ. Health Part A 67, 297-329 (2004).
    • (2004) J. Toxicol. Environ. Health Part A , vol.67 , pp. 297-329
    • Ginsberg, G.1    Hattis, D.2    Russ, A.3    Sonawane, B.4
  • 28
    • 52649085416 scopus 로고    scopus 로고
    • Physiology-based simulations of a pathological condition: Prediction of pharmacokinetics in patients with liver cirrhosis
    • Edginton, A.N. & Willmann, S. Physiology-based simulations of a pathological condition: prediction of pharmacokinetics in patients with liver cirrhosis. Clin. Pharmacokinet. 47, 743-752 (2008).
    • (2008) Clin. Pharmacokinet. , vol.47 , pp. 743-752
    • Edginton, A.N.1    Willmann, S.2
  • 29
    • 4444253244 scopus 로고    scopus 로고
    • Juvenile animal studies: Testing strategies and design
    • Hurtt, M.E. et al. Juvenile animal studies: testing strategies and design. Birth Defects Res. B Dev. Reprod. Toxicol. 71, 281-288 (2004).
    • (2004) Birth Defects Res. B Dev. Reprod. Toxicol. , vol.71 , pp. 281-288
    • Hurtt, M.E.1
  • 30
    • 34248594910 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research. February Accessed 16 December 2011
    • US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry: Nonclinical Safety Evaluation of Pediatric Drug Products, February 2006 〈http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm079247.pdf〉. Accessed 16 December 2011.
    • (2006) Guidance for Industry: Nonclinical Safety Evaluation of Pediatric Drug Products
  • 32
    • 80051499168 scopus 로고    scopus 로고
    • Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants
    • Parrott, N. et al. Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants. Clin. Pharmacokinet. 50, 613-623 (2011).
    • (2011) Clin. Pharmacokinet. , vol.50 , pp. 613-623
    • Parrott, N.1
  • 33
    • 77953358404 scopus 로고    scopus 로고
    • Juvenile animal testing in drug development - Is it useful?
    • Baldrick, P. Juvenile animal testing in drug development - is it useful? Regul. Toxicol. Pharmacol. 57, 291-299 (2010).
    • (2010) Regul. Toxicol. Pharmacol. , vol.57 , pp. 291-299
    • Baldrick, P.1
  • 34
    • 78650720051 scopus 로고    scopus 로고
    • Whole-body physiologically based pharmacokinetic model for nutlin-3a in mice after intravenous and oral administration
    • Zhang, F. et al. Whole-body physiologically based pharmacokinetic model for nutlin-3a in mice after intravenous and oral administration. Drug Metab. Dispos. 39, 15-21 (2011).
    • (2011) Drug Metab. Dispos. , vol.39 , pp. 15-21
    • Zhang, F.1
  • 35
    • 34249056589 scopus 로고    scopus 로고
    • A physiologically based pharmacokinetic model of docetaxel disposition: From mouse to man
    • Bradshaw-Pierce, E.L., Eckhardt, S.G. & Gustafson, D.L. A physiologically based pharmacokinetic model of docetaxel disposition: from mouse to man. Clin. Cancer Res. 13, 2768-2776 (2007).
    • (2007) Clin. Cancer Res. , vol.13 , pp. 2768-2776
    • Bradshaw-Pierce, E.L.1    Eckhardt, S.G.2    Gustafson, D.L.3
  • 36
    • 0037313517 scopus 로고    scopus 로고
    • Modern biomedical research: An internally self-consistent universe with little contact with medical reality?
    • Horrobin, D.F. Modern biomedical research: an internally self-consistent universe with little contact with medical reality? Nat. Rev. Drug Discov. 2, 151-154 (2003).
    • (2003) Nat. Rev. Drug Discov. , vol.2 , pp. 151-154
    • Horrobin, D.F.1
  • 37
    • 14044261316 scopus 로고    scopus 로고
    • What's wrong with our cancer models?
    • Kamb, A. What's wrong with our cancer models? Nat. Rev. Drug Discov. 4, 161-165 (2005).
    • (2005) Nat. Rev. Drug Discov. , vol.4 , pp. 161-165
    • Kamb, A.1
  • 38
  • 39
    • 34547839628 scopus 로고    scopus 로고
    • An age-dependent physiologically based pharmacokinetic/pharmacodynamic model for the organophosphorus insecticide chlorpyrifos in the preweanling rat
    • Timchalk, C., Kousba, A.A. & Poet, T.S. An age-dependent physiologically based pharmacokinetic/pharmacodynamic model for the organophosphorus insecticide chlorpyrifos in the preweanling rat. Toxicol. Sci. 98, 348-365 (2007).
    • (2007) Toxicol. Sci. , vol.98 , pp. 348-365
    • Timchalk, C.1    Kousba, A.A.2    Poet, T.S.3
  • 40
    • 79955547867 scopus 로고    scopus 로고
    • Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation
    • Burghaus, R. et al. Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation. PLoS ONE 6, e17626 (2011).
    • (2011) PLoS ONE , vol.6
    • Burghaus, R.1
  • 41
    • 33646123064 scopus 로고    scopus 로고
    • Application of physiology-based pharmacokinetic and pharmacodynamic modeling to individualized target-controlled propofol infusions
    • Edginton, A.N., Schmitt, W. & Willmann, S. Application of physiology-based pharmacokinetic and pharmacodynamic modeling to individualized target-controlled propofol infusions. Adv. Ther. 23, 143-158 (2006).
    • (2006) Adv. Ther. , vol.23 , pp. 143-158
    • Edginton, A.N.1    Schmitt, W.2    Willmann, S.3
  • 42
    • 80054742108 scopus 로고    scopus 로고
    • Mechanism-based pharmacokinetic-pharmacodynamic modeling of the dopamine D2 receptor occupancy of olanzapine in rats
    • Johnson, M. et al. Mechanism-based pharmacokinetic-pharmacodynamic modeling of the dopamine D2 receptor occupancy of olanzapine in rats. Pharm. Res. 28, 2490-2504 (2011).
    • (2011) Pharm. Res. , vol.28 , pp. 2490-2504
    • Johnson, M.1
  • 43
    • 0037812407 scopus 로고    scopus 로고
    • Clinical pharmacokinetic/pharmacodynamic and physiologically based pharmacokinetic modeling in new drug development: The capecitabine experience
    • Blesch, K.S., Gieschke, R., Tsukamoto, Y., Reigner, B.G., Burger, H.U. & Steimer, J.L. Clinical pharmacokinetic/pharmacodynamic and physiologically based pharmacokinetic modeling in new drug development: the capecitabine experience. Invest. New Drugs 21, 195-223 (2003).
    • (2003) Invest. New Drugs , vol.21 , pp. 195-223
    • Blesch, K.S.1    Gieschke, R.2    Tsukamoto, Y.3    Reigner, B.G.4    Burger, H.U.5    Steimer, J.L.6
  • 44
    • 16844378936 scopus 로고    scopus 로고
    • Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis
    • Yim, D.S., Zhou, H., Buckwalter, M., Nestorov, I., Peck, C.C. & Lee, H. Population pharmacokinetic analysis and simulation of the time-concentration profile of etanercept in pediatric patients with juvenile rheumatoid arthritis. J. Clin. Pharmacol. 45, 246-256 (2005).
    • (2005) J. Clin. Pharmacol. , vol.45 , pp. 246-256
    • Yim, D.S.1    Zhou, H.2    Buckwalter, M.3    Nestorov, I.4    Peck, C.C.5    Lee, H.6
  • 45
    • 0037962096 scopus 로고    scopus 로고
    • Evaluation of the potential impact of pharmacokinetic differences on tissue dosimetry in offspring during pregnancy and lactation
    • rd. Evaluation of the potential impact of pharmacokinetic differences on tissue dosimetry in offspring during pregnancy and lactation. Regul. Toxicol. Pharmacol. 38, 1-16 (2003).
    • (2003) Regul. Toxicol. Pharmacol. , vol.38 , pp. 1-16
    • Gentry, P.R.1    Covington, T.R.2    Clewell III, H.J.3
  • 46
    • 0035085431 scopus 로고    scopus 로고
    • Physiological-model-based derivation of the adult and child pharmacokinetic intraspecies uncertainty factors for volatile organic compounds
    • Pelekis, M., Gephart, L.A. & Lerman, S.E. Physiological-model-based derivation of the adult and child pharmacokinetic intraspecies uncertainty factors for volatile organic compounds. Regul. Toxicol. Pharmacol. 33, 12-20 (2001).
    • (2001) Regul. Toxicol. Pharmacol. , vol.33 , pp. 12-20
    • Pelekis, M.1    Gephart, L.A.2    Lerman, S.E.3
  • 47
    • 0037436798 scopus 로고    scopus 로고
    • Physiological modeling of age-specific changes in the pharmacokinetics of organic chemicals in children
    • Price, K., Haddad, S. & Krishnan, K. Physiological modeling of age-specific changes in the pharmacokinetics of organic chemicals in children. J. Toxicol. Environ. Health Part A 66, 417-433 (2003).
    • (2003) J. Toxicol. Environ. Health Part A , vol.66 , pp. 417-433
    • Price, K.1    Haddad, S.2    Krishnan, K.3
  • 48
    • 43449090654 scopus 로고    scopus 로고
    • Renal clearance parameters for PBPK model analysis of early lifestage differences in the disposition of environmental toxicants
    • DeWoskin, R.S. & Thompson, C.M. Renal clearance parameters for PBPK model analysis of early lifestage differences in the disposition of environmental toxicants. Regul. Toxicol. Pharmacol. 51, 66-86 (2008).
    • (2008) Regul. Toxicol. Pharmacol. , vol.51 , pp. 66-86
    • DeWoskin, R.S.1    Thompson, C.M.2
  • 49
    • 79951653884 scopus 로고    scopus 로고
    • Knowledge-driven approaches for the guidance of first-in-children dosing
    • Edginton, A.N. Knowledge-driven approaches for the guidance of first-in-children dosing. Paediatr. Anaesth. 21, 206-213 (2011).
    • (2011) Paediatr. Anaesth. , vol.21 , pp. 206-213
    • Edginton, A.N.1
  • 50
    • 79951615778 scopus 로고    scopus 로고
    • 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
    • Johnson, T.N. & 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. 21, 291-301 (2011).
    • (2011) Paediatr. Anaesth. , vol.21 , pp. 291-301
    • Johnson, T.N.1    Rostami-Hodjegan, A.2
  • 51
    • 20644470553 scopus 로고    scopus 로고
    • Tripartite meeting. Paediatric regulatory guidelines: Do they help in optimizing dose selection for children?
    • Baber, N.S. Tripartite meeting. Paediatric regulatory guidelines: do they help in optimizing dose selection for children? Br. J. Clin. Pharmacol. 59, 660-662 (2005).
    • (2005) Br. J. Clin. Pharmacol. , vol.59 , pp. 660-662
    • Baber, N.S.1
  • 52
    • 0035723305 scopus 로고    scopus 로고
    • Estimating the starting dose for entry into humans: Principles and practice
    • Reigner, B.G. & Blesch, K.S. Estimating the starting dose for entry into humans: principles and practice. Eur. J. Clin. Pharmacol. 57, 835-845 (2002).
    • (2002) Eur. J. Clin. Pharmacol. , vol.57 , pp. 835-845
    • Reigner, B.G.1    Blesch, K.S.2
  • 53
    • 70449887026 scopus 로고    scopus 로고
    • The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies
    • Muller, P.Y., Milton, M., Lloyd, P., Sims, J. & Brennan, F.R. The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies. Curr. Opin. Biotechnol. 20, 722-729 (2009).
    • (2009) Curr. Opin. Biotechnol. , vol.20 , pp. 722-729
    • Muller, P.Y.1    Milton, M.2    Lloyd, P.3    Sims, J.4    Brennan, F.R.5
  • 54
    • 34547842118 scopus 로고    scopus 로고
    • Predicting the active doses in humans from animal studies: A novel approach in oncology
    • Rocchetti, M., Simeoni, M., Pesenti, E., De Nicolao, G. & Poggesi, I. Predicting the active doses in humans from animal studies: a novel approach in oncology. Eur. J. Cancer 43, 1862-1868 (2007).
    • (2007) Eur. J. Cancer , vol.43 , pp. 1862-1868
    • Rocchetti, M.1    Simeoni, M.2    Pesenti, E.3    De Nicolao, G.4    Poggesi, I.5
  • 55
    • 40549143738 scopus 로고    scopus 로고
    • Facilitation of drug evaluation in children by population methods and modelling
    • Tod, M., Jullien, V. & Pons, G. Facilitation of drug evaluation in children by population methods and modelling. Clin. Pharmacokinet. 47, 231-243 (2008).
    • (2008) Clin. Pharmacokinet. , vol.47 , pp. 231-243
    • Tod, M.1    Jullien, V.2    Pons, G.3
  • 56
  • 58
    • 85081147726 scopus 로고    scopus 로고
    • Modeling and simulation in pediatric research and development
    • (eds. Kimko, H. & Peck, C.), Springer Science + Business Media, New York
    • Barrett, JS. Modeling and simulation in pediatric research and development. In Clinical Trial Simulations: Applications & Trends (eds. Kimko, H. & Peck, C.), 401-433 (Springer Science + Business Media, New York, 2011).
    • (2011) Clinical Trial Simulations: Applications & Trends , pp. 401-433
    • Barrett, J.S.1
  • 59
    • 0032974197 scopus 로고    scopus 로고
    • Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: Concepts and perspectives
    • Derendorf, H. & Meibohm, B. Modeling of pharmacokinetic/ pharmacodynamic (PK/PD) relationships: concepts and perspectives. Pharm. Res. 16, 176-185 (1999).
    • (1999) Pharm. Res. , vol.16 , pp. 176-185
    • Derendorf, H.1    Meibohm, B.2
  • 60
    • 77149177347 scopus 로고    scopus 로고
    • On setting the first dose in man: Quantitating biotherapeutic drug-target binding through pharmacokinetic and pharmacodynamic models
    • Lowe, P.J., Tannenbaum, S., Wu, K., Lloyd, P. & Sims, J. On setting the first dose in man: quantitating biotherapeutic drug-target binding through pharmacokinetic and pharmacodynamic models. Basic Clin. Pharmacol. Toxicol. 106, 195-209 (2010).
    • (2010) Basic Clin. Pharmacol. Toxicol. , vol.106 , pp. 195-209
    • Lowe, P.J.1    Tannenbaum, S.2    Wu, K.3    Lloyd, P.4    Sims, J.5
  • 61
    • 20644467987 scopus 로고    scopus 로고
    • How children's responses to drugs differ from adults
    • Stephenson, T. How children's responses to drugs differ from adults. Br. J. Clin. Pharmacol. 59, 670-673 (2005).
    • (2005) Br. J. Clin. Pharmacol. , vol.59 , pp. 670-673
    • Stephenson, T.1
  • 62
    • 78650500434 scopus 로고    scopus 로고
    • A maturation model for midazolam clearance
    • Anderson, B.J. & Larsson, P. A maturation model for midazolam clearance. Paediatr. Anaesth. 21, 302-308 (2011).
    • (2011) Paediatr. Anaesth. , vol.21 , pp. 302-308
    • Anderson, B.J.1    Larsson, P.2
  • 63
    • 0142010672 scopus 로고    scopus 로고
    • Modeling interindividual variation in physiological factors used in PBPK models of humans
    • Price, P.S. et al. Modeling interindividual variation in physiological factors used in PBPK models of humans. Crit. Rev. Toxicol. 33, 469-503 (2003).
    • (2003) Crit. Rev. Toxicol. , vol.33 , pp. 469-503
    • Price, P.S.1
  • 64
    • 34249905607 scopus 로고    scopus 로고
    • Development of a physiology-based whole-body population model for assessing the influence of individual variability on the pharmacokinetics of drugs
    • Willmann, S. et al. Development of a physiology-based whole-body population model for assessing the influence of individual variability on the pharmacokinetics of drugs. J. Pharmacokinet. Pharmacodyn. 34, 401-431 (2007).
    • (2007) J. Pharmacokinet. Pharmacodyn. , vol.34 , pp. 401-431
    • Willmann, S.1
  • 65
    • 34447505925 scopus 로고    scopus 로고
    • Model-based Drug Development for Oncology Agents
    • Barrett, J. et al. Model-based Drug Development for Oncology Agents. Exp. Opin. Drug Discov. 2, 185-209 (2007).
    • (2007) Exp. Opin. Drug Discov. , vol.2 , pp. 185-209
    • Barrett, J.1
  • 66
    • 71049148896 scopus 로고    scopus 로고
    • Modelling the genesis and treatment of cancer: The potential role of physiologically based pharmacodynamics
    • Steimer, J.L. et al. Modelling the genesis and treatment of cancer: the potential role of physiologically based pharmacodynamics. Eur. J. Cancer 46, 21-32 (2010).
    • (2010) Eur. J. Cancer , vol.46 , pp. 21-32
    • Steimer, J.L.1
  • 67
    • 0033887699 scopus 로고    scopus 로고
    • Differences in sensitivity of children and adults to chemical toxicity: The NAS panel report
    • Bruckner, J.V. Differences in sensitivity of children and adults to chemical toxicity: the NAS panel report. Regul. Toxicol. Pharmacol. 31, 280-285 (2000).
    • (2000) Regul. Toxicol. Pharmacol. , vol.31 , pp. 280-285
    • Bruckner, J.V.1
  • 69
    • 0141673589 scopus 로고    scopus 로고
    • Atopic diseases of childhood
    • Stone, K.D. Atopic diseases of childhood. Curr. Opin. Pediatr. 15, 495-511 (2003).
    • (2003) Curr. Opin. Pediatr. , vol.15 , pp. 495-511
    • Stone, K.D.1
  • 70
    • 66649131390 scopus 로고    scopus 로고
    • Risk of dementia and AD with prior exposure to NSAIDs in an elderly community-based cohort
    • Breitner, J.C. et al. Risk of dementia and AD with prior exposure to NSAIDs in an elderly community-based cohort. Neurology 72, 1899-1905 (2009).
    • (2009) Neurology , vol.72 , pp. 1899-1905
    • Breitner, J.C.1
  • 71
    • 55549143695 scopus 로고    scopus 로고
    • Intestinal metabolism and transport of drugs in children: The effects of age and disease
    • Johnson, T.N. & Thomson, M. Intestinal metabolism and transport of drugs in children: the effects of age and disease. J. Pediatr. Gastroenterol. Nutr. 47, 3-10 (2008).
    • (2008) J. Pediatr. Gastroenterol. Nutr. , vol.47 , pp. 3-10
    • Johnson, T.N.1    Thomson, M.2
  • 72
    • 70349595490 scopus 로고    scopus 로고
    • Can we get the necessary clinical trials in children and avoid the unnecessary ones?
    • Hoppu, K. Can we get the necessary clinical trials in children and avoid the unnecessary ones? Eur. J. Clin. Pharmacol. 65, 747-748 (2009).
    • (2009) Eur. J. Clin. Pharmacol. , vol.65 , pp. 747-748
    • Hoppu, K.1
  • 73
    • 85009092858 scopus 로고    scopus 로고
    • Physiologically based pharmacokinetic modeling: Methodology, applications, and limitations with a focus on its role in pediatric drug development
    • 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. 90, 74-61 (2011).
    • (2011) J. Biomed. Biotechnol. , vol.90 , pp. 74-161
    • Khalil, F.1    Läer, S.2
  • 74
    • 78951482203 scopus 로고    scopus 로고
    • Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review
    • Zhao, P. et al. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin. Pharmacol. Ther. 89, 259-267 (2011).
    • (2011) Clin. Pharmacol. Ther. , vol.89 , pp. 259-267
    • Zhao, P.1
  • 75
    • 84862777920 scopus 로고    scopus 로고
    • The role of physiologically based pharmacokinetic modeling in regulatory review
    • Huang, S.M. & Rowland, M. The role of physiologically based pharmacokinetic modeling in regulatory review. Clin. Pharmacol. Ther. 91, 542-549 (2012).
    • (2012) Clin. Pharmacol. Ther. , vol.91 , pp. 542-549
    • Huang, S.M.1    Rowland, M.2


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