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Volumn 2, Issue 6, 2009, Pages 609-617

Challenges in conducting clinical trials in children: Approaches for improving performance

Author keywords

Economics; Efficacy; Ethics; Modeling and simulation; Pediatric; Pharmacodynamics; Pharmacokinetic

Indexed keywords

CHILD; CHILD HEALTH; CLINICAL STUDY; DRUG INDUSTRY; DRUG LABELING; DRUG MANUFACTURE; DRUG MARKETING; DRUG RESEARCH; DRUG SCREENING; ECONOMIC ASPECT; GOVERNMENT REGULATION; HEALTH HAZARD; HUMAN; MEDICAL ETHICS; PHARMACODYNAMICS; REVIEW; SIMULATION;

EID: 70549097988     PISSN: 17512433     EISSN: None     Source Type: Journal    
DOI: 10.1586/ecp.09.40     Document Type: Review
Times cited : (51)

References (65)
  • 1
    • 33947355479 scopus 로고    scopus 로고
    • Future of pediatric therapeutics: Reauthorization of BPCA and PREA
    • DOI 10.1038/sj.clpt.6100109, PII 6100109
    • Ward RM, Kauffman R. Future of pediatric therapeutics: reauthorization of BPCA and PREA. Clin. Pharmacol. Ther. 81, 477-479 (2007). (Pubitemid 46452311)
    • (2007) Clinical Pharmacology and Therapeutics , vol.81 , Issue.4 , pp. 477-479
    • Ward, R.M.1    Kauffman, R.2
  • 2
    • 64149122147 scopus 로고    scopus 로고
    • Straight talk with... Agnes Saint Raymond
    • Interview by Genevive Bjorn
    • Saint-Raymond A. Straight talk with ... Agnes Saint Raymond. Interview by Genevive Bjorn. Nat. Med. 15, 354-355 (2009).
    • (2009) Nat. Med. , vol.15 , pp. 354-355
    • Saint-Raymond, A.1
  • 3
    • 58149354502 scopus 로고    scopus 로고
    • The European paediatric initiative: 1 Year of experience
    • Saint-Raymond A, Seigneuret N. The European paediatric initiative: 1 year of experience. Paediatr. Drugs 11, 9-10 (2009).
    • (2009) Paediatr. Drugs , vol.11 , pp. 9-10
    • Saint-Raymond, A.1    Seigneuret, N.2
  • 4
    • 38349168789 scopus 로고    scopus 로고
    • Communicating with the FDA: The 'third rail' of a new model for drug development
    • Stanski DR, Orloff JJ. Communicating with the FDA: the 'third rail' of a new model for drug development. J. Clin. Pharmacol. 48, 144-145 (2008).
    • (2008) J. Clin. Pharmacol. , vol.48 , pp. 144-145
    • Stanski, D.R.1    Orloff, J.J.2
  • 5
    • 33750085880 scopus 로고    scopus 로고
    • Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative
    • Overview of ethical issue pertaining to study of drugs in children
    • Baer GR, Nelson RM. Ethical challenges in neonatal research: summary report of the ethics group of the newborn drug development initiative. Clin. Ther. 28, 1399-1407 (2006). •• Overview of ethical issue pertaining to study of drugs in children.
    • (2006) Clin. Ther. , vol.28 , pp. 1399-1407
    • Baer, G.R.1    Nelson, R.M.2
  • 6
    • 53549131496 scopus 로고    scopus 로고
    • European survey on ethical and legal framework of clinical trials in paediatrics: Results and perspectives
    • 121-122
    • Altavilla A, Giaquinto C, Ceci A. European survey on ethical and legal framework of clinical trials in paediatrics: results and perspectives. J. Int. Bioethique 19, 17-48, 121-122 (2008).
    • (2008) J. Int. Bioethique , vol.19 , pp. 17-48
    • Altavilla, A.1    Giaquinto, C.2    Ceci, A.3
  • 9
    • 55449093315 scopus 로고    scopus 로고
    • Clinical trials of drugs used off-label in neonates: Ethical issues and alternative study designs
    • Amin SB, McDermott MP, Shamoo AE. Clinical trials of drugs used off-label in neonates: ethical issues and alternative study designs. Account Res. 15, 168-187 (2008).
    • (2008) Account Res. , vol.15 , pp. 168-187
    • Amin, S.B.1    McDermott, M.P.2    Shamoo, A.E.3
  • 10
    • 0033637935 scopus 로고    scopus 로고
    • Off label and unlicensed drug use among French office based paediatricians
    • Chalumeau M, Treluyer JM, Salanave B et al. Off label and unlicensed drug use among French office based paediatricians. Arch. Dis. Child. 83, 502-505 (2000).
    • (2000) Arch. Dis. Child. , vol.83 , pp. 502-505
    • Chalumeau, M.1    Treluyer, J.M.2    Salanave, B.3
  • 11
    • 34247362803 scopus 로고    scopus 로고
    • Drug related problems and off-label drug treatment in children as seen at a drug information centre
    • DOI 10.1007/s00431-006-0385-8
    • Kimland E, Bergman U, Lindemalm S, Bottiger Y. Drug related problems and off-label drug treatment in children as seen at a drug information centre. Eur. J. Pediatr. 166, 527-532 (2007). (Pubitemid 46643706)
    • (2007) European Journal of Pediatrics , vol.166 , Issue.6 , pp. 527-532
    • Kimland, E.1    Bergman, U.2    Lindemalm, S.3    Bottiger, Y.4
  • 12
    • 33747495601 scopus 로고    scopus 로고
    • Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety
    • DOI 10.1517/14740338.5.5.703
    • 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). •• Thorough review of off-label use in pediatrics and the risk of this practice. (Pubitemid 44322888)
    • (2006) Expert Opinion on Drug Safety , vol.5 , Issue.5 , pp. 703-718
    • Cuzzolin, L.1    Atzei, A.2    Fanos, V.3
  • 13
    • 0141857724 scopus 로고    scopus 로고
    • Developmental pharmacology - Drug disposition, action, and therapy in infants and children
    • Comprehensive review of pharmacology differences between children and adults
    • 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. 349, 1157-1167 (2003). •• Comprehensive review of pharmacology differences between children and adults.
    • (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
  • 14
    • 34547913838 scopus 로고    scopus 로고
    • Children with HIV are not small adults: What is different in pharmacology?
    • DOI 10.1097/COH.0b013e3282ced13f, PII 0122292920070900000008
    • L'Homme R, Warris A, Gibb D, Burger D. Children with HIV are not small adults: what is different in pharmacology? Curr. Opin. HIV AIDS 2, 405-409 (2007). (Pubitemid 47254736)
    • (2007) Current Opinion in HIV and AIDS , vol.2 , Issue.5 , pp. 405-409
    • L'Homme, R.1    Warris, A.2    Gibb, D.3    Burger, D.4
  • 15
    • 33746803672 scopus 로고    scopus 로고
    • Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children
    • Review of in vitro to in vivo scaling for predicting drug effect in children
    • Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin. Pharmacokinet. 45, 931-956 (2006). •• Review of in vitro to in vivo scaling for predicting drug effect in children.
    • (2006) Clin. Pharmacokinet. , vol.45 , pp. 931-956
    • Johnson, T.N.1    Rostami-Hodjegan, A.2    Tucker, G.T.3
  • 17
    • 30444445571 scopus 로고    scopus 로고
    • Changes in liver volume from birth to adulthood: A meta-analysis
    • DOI 10.1002/lt.20519
    • Johnson TN, Tucker GT, Tanner MS, Rostami-Hodjegan A. Changes in liver volume from birth to adulthood: a meta-analysis. Liver Transpl. 11, 1481-1493 (2005). (Pubitemid 43072624)
    • (2005) Liver Transplantation , vol.11 , Issue.12 , pp. 1481-1493
    • Johnson, T.N.1    Tucker, G.T.2    Tanner, M.S.3    Rostami-Hodjegan, A.4
  • 19
    • 0036068334 scopus 로고    scopus 로고
    • Developmental changes in the expression of enterocytic and hepatic cytochromes P4501A in rat
    • Johnson TN, Tanner MS, Tucker GT. Developmental changes in the expression of enterocytic and hepatic cytochromes P4501A in rat. Xenobiotica 32, 595-604 (2002).
    • (2002) Xenobiotica , vol.32 , pp. 595-604
    • Johnson, T.N.1    Tanner, M.S.2    Tucker, G.T.3
  • 20
    • 0037974213 scopus 로고    scopus 로고
    • Selection of the first-time dose in humans: Comparison of different approaches based on interspecies scaling of clearance
    • Mahmood I, Green MD, Fisher JE. Selection of the first-time dose in humans: comparison of different approaches based on interspecies scaling of clearance. J. Clin. Pharmacol. 43, 692-697 (2003). (Pubitemid 36759146)
    • (2003) Journal of Clinical Pharmacology , vol.43 , Issue.7 , pp. 692-697
    • Mahmood, I.1    Green, M.D.2    Fisher, J.E.3
  • 21
    • 33645821243 scopus 로고    scopus 로고
    • Pharmacological research in pediatrics: From neonates to adolescents
    • Rakhmanina NY, van den Anker JN. Pharmacological research in pediatrics: from neonates to adolescents. Adv. Drug Deliv. Rev. 58, 4-14 (2006).
    • (2006) Adv. Drug Deliv. Rev. , vol.58 , pp. 4-14
    • Rakhmanina, N.Y.1    Van Den Anker, J.N.2
  • 22
    • 45549098837 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of intravenously administered anesthetic drugs: Concepts and lessons for drug development
    • Kern SE, Stanski DR. Pharmacokinetics and pharmacodynamics of intravenously administered anesthetic drugs: concepts and lessons for drug development. Clin. Pharmacol. Ther. 84, 153-157 (2008).
    • (2008) Clin. Pharmacol. Ther. , vol.84 , pp. 153-157
    • Kern, S.E.1    Stanski, D.R.2
  • 23
    • 34547944987 scopus 로고    scopus 로고
    • Developing paediatric medicines: Identifying the needs and recognizing the challenges
    • DOI 10.1211/jpp.59.8.0001
    • Ernest TB, Elder DP, Martini LG, Roberts M, Ford JL. Developing paediatric medicines: identifying the needs and recognizing the challenges. J. Pharm. Pharmacol. 59, 1043-1055 (2007). (Pubitemid 47265351)
    • (2007) Journal of Pharmacy and Pharmacology , vol.59 , Issue.8 , pp. 1043-1055
    • Ernest, T.B.1    Elder, D.P.2    Martini, L.G.3    Roberts, M.4    Ford, J.L.5
  • 24
    • 41749105125 scopus 로고    scopus 로고
    • The problems in scaling adult drug doses to children
    • Johnson TN. 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
  • 25
    • 33748956318 scopus 로고    scopus 로고
    • Population clinical pharmacology of children: General principles
    • DOI 10.1007/s00431-006-0188-y
    • Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: general principles. Eur. J. Pediatr. 165, 741-746 (2006). (Pubitemid 44440510)
    • (2006) European Journal of Pediatrics , vol.165 , Issue.11 , pp. 741-746
    • Anderson, B.J.1    Allegaert, K.2    Holford, N.H.G.3
  • 26
    • 33750344295 scopus 로고    scopus 로고
    • Population clinical pharmacology of children: Modelling covariate effects
    • DOI 10.1007/s00431-006-0189-x
    • Anderson BJ, Allegaert K, Holford NH. Population clinical pharmacology of children: modelling covariate effects. Eur. J. Pediatr. 165, 819-829 (2006). (Pubitemid 44627767)
    • (2006) European Journal of Pediatrics , vol.165 , Issue.12 , pp. 819-829
    • Anderson, B.J.1    Allegaert, K.2    Holford, N.H.G.3
  • 27
    • 0038504098 scopus 로고    scopus 로고
    • A Bayesian approach for the estimation of pharmacokinetic parameters in children
    • Mahmood I. A Bayesian approach for the estimation of pharmacokinetic parameters in children. Am. J. Ther. 10, 88-92 (2003).
    • (2003) Am. J. Ther. , vol.10 , pp. 88-92
    • Mahmood, I.1
  • 28
    • 1842738250 scopus 로고    scopus 로고
    • A comparison of two sparse sampling population pharmacokinetic approaches for the estimation of pharmacokinetic parameters in children
    • Mahmood I, Tammara V. A comparison of two sparse sampling population pharmacokinetic approaches for the estimation of pharmacokinetic parameters in children. Int. J. Clin. Pharmacol. Ther. 42, 240-245 (2004). (Pubitemid 38477440)
    • (2004) International Journal of Clinical Pharmacology and Therapeutics , vol.42 , Issue.4 , pp. 240-245
    • Mahmood, I.1    Tammara, V.2
  • 29
    • 30444448534 scopus 로고    scopus 로고
    • Population pharmacokinetic studies in pediatrics: Issues in design and analysis
    • DOI 10.1208/aapsj070248, 48
    • Meibohm B, Laer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 7, E475-E487 (2005). (Pubitemid 43071326)
    • (2005) AAPS Journal , vol.7 , Issue.2
    • Meibohm, B.1    Laer, S.2    Panetta, J.C.3    Barrett, J.S.4
  • 30
    • 40549143738 scopus 로고    scopus 로고
    • Facilitation of drug evaluation in children by population methods and modelling
    • Clinical application of modeling and simulation to pediatric studies
    • Tod M, Jullien V, Pons G. Facilitation of drug evaluation in children by population methods and modelling. Clin. Pharmacokinet. 47, 231-243 (2008). •• Clinical application of modeling and simulation to pediatric studies.
    • (2008) Clin. Pharmacokinet. , vol.47 , pp. 231-243
    • Tod, M.1    Jullien, V.2    Pons, G.3
  • 31
    • 0037374394 scopus 로고    scopus 로고
    • Use of healthy children as volunteers in drug studies: The ethical debate
    • DOI 10.1067/mcp.2003.16
    • Koren G, Kearns GL, Reed M, Pons G. Use of healthy children as volunteers in drug studies: the ethical debate. Clin. Pharmacol. Ther. 73, 147-152 (2003). (Pubitemid 36269665)
    • (2003) Clinical Pharmacology and Therapeutics , vol.73 , Issue.3 , pp. 147-152
    • Koren, G.1    Kearns, G.L.2    Reed, M.3    Pons, G.4
  • 32
    • 63649092684 scopus 로고    scopus 로고
    • 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
    • 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. 81, 1557-1563 (2009).
    • (2009) Anal. Chem. , vol.81 , pp. 1557-1563
    • Spooner, N.1    Lad, R.2    Barfield, M.3
  • 33
    • 53149083426 scopus 로고    scopus 로고
    • The economic returns of pediatric clinical trials of antihypertensive drugs
    • Baker-Smith CM, Benjamin DK Jr, Grabowski HG et al. The economic returns of pediatric clinical trials of antihypertensive drugs. Am. Heart J. 156, 682-688 (2008).
    • (2008) Am. Heart J. , vol.156 , pp. 682-688
    • Baker-Smith, C.M.1    Benjamin Jr., D.K.2    Grabowski, H.G.3
  • 34
    • 33846878293 scopus 로고    scopus 로고
    • Economic return of clinical trials performed under the pediatric exclusivity program
    • Li JS, Eisenstein EL, Grabowski HG et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA 297, 480-488 (2007).
    • (2007) JAMA , vol.297 , pp. 480-488
    • Li, J.S.1    Eisenstein, E.L.2    Grabowski, H.G.3
  • 35
    • 58149354492 scopus 로고    scopus 로고
    • The National Institutes of Health and the Best Pharmaceuticals for Children Act
    • Zajicek A. The National Institutes of Health and the Best Pharmaceuticals for Children Act. Paediatr. Drugs 11, 45-47 (2009).
    • (2009) Paediatr. Drugs , vol.11 , pp. 45-47
    • Zajicek, A.1
  • 36
    • 34250880825 scopus 로고    scopus 로고
    • Stimulation programs for pediatric drug research - Do children really benefit?
    • DOI 10.1007/s00431-006-0381-z
    • Boots I, Sukhai RN, Klein RH et al. Stimulation programs for pediatric drug research - do children really benefit? Eur. J. Pediatr. 166, 849-855 (2007). •• Assesses the influence of adult medicine on pediatric exclusivity efforts to date. (Pubitemid 46988181)
    • (2007) European Journal of Pediatrics , vol.166 , Issue.8 , pp. 849-855
    • Boots, I.1    Sukhai, R.N.2    Klein, R.H.3    Holl, R.A.4    Wit, J.M.5    Cohen, A.F.6    Burggraaf, J.7
  • 37
    • 20644445855 scopus 로고    scopus 로고
    • Effect of the Pediatric Exclusivity Provision on children's access to medicines
    • DOI 10.1111/j.1365-2125.2005.02327.x
    • Grieve J, Tordoff J, Reith D, Norris P. Effect of the pediatric exclusivity provision on children's access to medicines. Br. J. Clin. Pharmacol. 59, 730-735 (2005). (Pubitemid 40835509)
    • (2005) British Journal of Clinical Pharmacology , vol.59 , Issue.6 , pp. 730-735
    • Grieve, J.1    Tordoff, J.2    Reith, D.3    Norris, P.4
  • 38
    • 58149339919 scopus 로고    scopus 로고
    • The global alliance for pediatric pharmacology: The future is here and now
    • Koren G, Rieder M, MacLeod SM. The global alliance for pediatric pharmacology: the future is here and now. Paediatr. Drugs 11, 4-5 (2009).
    • (2009) Paediatr. Drugs , vol.11 , pp. 4-5
    • Koren, G.1    Rieder, M.2    MacLeod, S.M.3
  • 39
    • 55849102471 scopus 로고    scopus 로고
    • Population pharmacokinetics of fluconazole in young infants
    • Wade KC, Wu D, Kaufman DA et al. Population pharmacokinetics of fluconazole in young infants. Antimicrob. Agents Chemother. 52, 4043-4049 (2008).
    • (2008) Antimicrob. Agents Chemother. , vol.52 , pp. 4043-4049
    • Wade, K.C.1    Wu, D.2    Kaufman, D.A.3
  • 40
    • 51649091488 scopus 로고    scopus 로고
    • Safety monitoring of drugs receiving pediatric marketing exclusivity
    • Smith PB, Benjamin DK Jr, Murphy MD et al. Safety monitoring of drugs receiving pediatric marketing exclusivity. Pediatrics 122, E628-E633 (2008).
    • (2008) Pediatrics , vol.122
    • Smith, P.B.1    Benjamin Jr., D.K.2    Murphy, M.D.3
  • 41
    • 33748646758 scopus 로고    scopus 로고
    • Peer-reviewed publication of clinical trials completed for pediatric exclusivity
    • Benjamin DK Jr, Smith PB, Murphy MD et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 296, 1266-1273 (2006).
    • (2006) JAMA , vol.296 , pp. 1266-1273
    • Benjamin Jr., D.K.1    Smith, P.B.2    Murphy, M.D.3
  • 42
    • 54749152234 scopus 로고    scopus 로고
    • Publication of clinical trials supporting successful new drug applications: A literature analysis
    • Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 5, E191 (2008).
    • (2008) PLoS Med. , vol.5
    • Lee, K.1    Bacchetti, P.2    Sim, I.3
  • 44
    • 39649084919 scopus 로고    scopus 로고
    • The FDA critical path initiative and its influence on new drug development
    • DOI 10.1146/annurev.med.59.090506.155819
    • Woodcock J, Woosley R. The FDA critical path initiative and its influence on new drug development. Annu. Rev. Med. 59, 1-12 (2008). (Pubitemid 351287920)
    • (2008) Annual Review of Medicine , vol.59 , pp. 1-12
    • Woodcock, J.1    Woosley, R.2
  • 45
    • 41149180911 scopus 로고    scopus 로고
    • Mechanism-based concepts of size and maturity in pharmacokinetics
    • Summary of allometric principles applied to pharmacokinetic modeling
    • Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu. Rev. Pharmacol. Toxicol. 48, 303-332 (2008). •• Summary of allometric principles applied to pharmacokinetic modeling.
    • (2008) Annu. Rev. Pharmacol. Toxicol. , vol.48 , pp. 303-332
    • Anderson, B.J.1    Holford, N.H.2
  • 46
    • 33745584148 scopus 로고    scopus 로고
    • Development and evaluation of a generic physiologically based pharmacokinetic model for children
    • DOI 10.2165/00003088-200645100-00005
    • Edginton AN, Schmitt W, Willmann S. Development and evaluation of a generic physiologically based pharmacokinetic model for children. Clin. Pharmacokinet. 45, 1013-1034 (2006). •• Summary of physiologic based modeling for scaling to children. (Pubitemid 44436004)
    • (2006) Clinical Pharmacokinetics , vol.45 , Issue.10 , pp. 1013-1034
    • Edginton, A.N.1    Schmitt, W.2    Willmann, S.3
  • 47
    • 52649130373 scopus 로고    scopus 로고
    • Whole body physiologically-based pharmacokinetic models: Their use in clinical drug development
    • Edginton AN, Theil FP, Schmitt W, Willmann S. Whole body physiologically-based pharmacokinetic models: their use in clinical drug development. Expert Opin. Drug Metab. Toxicol. 4, 1143-1152 (2008).
    • (2008) Expert Opin. Drug Metab. Toxicol. , vol.4 , pp. 1143-1152
    • Edginton, A.N.1    Theil, F.P.2    Schmitt, W.3    Willmann, S.4
  • 48
    • 20644445856 scopus 로고    scopus 로고
    • Modelling approaches to dose estimation in children
    • Johnson TN. Modelling approaches to dose estimation in children. Br. J. Clin. Pharmacol. 59, 663-669 (2005).
    • (2005) Br. J. Clin. Pharmacol. , vol.59 , pp. 663-669
    • Johnson, T.N.1
  • 49
    • 34447512467 scopus 로고    scopus 로고
    • Prediction of drug clearance in children: Impact of allometric exponents, body weight, and age
    • DOI 10.1097/FTD.0b013e318042d3c4, PII 0000769120070600000002
    • Mahmood I. Prediction of drug clearance in children: impact of allometric exponents, body weight, and age. Ther. Drug Monit. 29, 271-278 (2007). (Pubitemid 47262255)
    • (2007) Therapeutic Drug Monitoring , vol.29 , Issue.3 , pp. 271-278
    • Mahmood, I.1
  • 50
    • 69949109408 scopus 로고    scopus 로고
    • Pharmacokinetic allometric scaling of antibodies: Application to the first-in-human dose estimation
    • Mahmood I. Pharmacokinetic allometric scaling of antibodies: application to the first-in-human dose estimation. J. Pharm. Sci. 98(10), 3850-3861 (2009).
    • (2009) J. Pharm. Sci. , vol.98 , Issue.10 , pp. 3850-3861
    • Mahmood, I.1
  • 52
    • 34250638541 scopus 로고    scopus 로고
    • Pharmacometrics at FDA: Evolution and impact on decisions
    • Powell JR, Gobburu JV. Pharmacometrics at FDA: evolution and impact on decisions. Clin. Pharmacol. Ther. 82, 97-102 (2007).
    • (2007) Clin. Pharmacol. Ther. , vol.82 , pp. 97-102
    • Powell, J.R.1    Gobburu, J.V.2
  • 53
    • 38349115335 scopus 로고    scopus 로고
    • Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: Impact of FDA pharmacometrics during 2004-2006
    • Wang Y, Bhattaram AV, Jadhav PR et al. Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006. J. Clin. Pharmacol. 48, 146-156 (2008).
    • (2008) J. Clin. Pharmacol. , vol.48 , pp. 146-156
    • Wang, Y.1    Bhattaram, A.V.2    Jadhav, P.R.3
  • 55
    • 0036148636 scopus 로고    scopus 로고
    • Potential benefit of Bayesian forecasting for therapeutic drug monitoring in neonates
    • DOI 10.1097/00007691-200202000-00002
    • Pons G, Treluyer JM, Dimet J, Merle Y. Potential benefit of Bayesian forecasting for therapeutic drug monitoring in neonates. Ther. Drug Monit. 24, 9-14 (2002). (Pubitemid 34106724)
    • (2002) Therapeutic Drug Monitoring , vol.24 , Issue.1 , pp. 9-14
    • Pons, G.1    Treluyer, J.-M.2    Dimet, J.3    Merle, Y.4
  • 56
    • 70349227353 scopus 로고    scopus 로고
    • An informatics approach to assess pediatric pharmacotherapy: Design and implementation of a hospital drug utilization system
    • Zuppa A, Vijayakumar S, Jayaraman B et al. An informatics approach to assess pediatric pharmacotherapy: design and implementation of a hospital drug utilization system. J. Clin. Pharmacol. 47, 1172-1180 (2007).
    • (2007) J. Clin. Pharmacol. , vol.47 , pp. 1172-1180
    • Zuppa, A.1    Vijayakumar, S.2    Jayaraman, B.3
  • 57
    • 54249163567 scopus 로고    scopus 로고
    • Morphine pharmacokinetics and pharmacodynamics in preterm and term neonates: Secondary results from the NEOPAIN trial
    • Anand KJ, Anderson BJ, Holford NH et al. Morphine pharmacokinetics and pharmacodynamics in preterm and term neonates: secondary results from the NEOPAIN trial. Br. J. Anaesth. 101, 680-689 (2008).
    • (2008) Br. J. Anaesth. , vol.101 , pp. 680-689
    • Anand, K.J.1    Anderson, B.J.2    Holford, N.H.3
  • 58
    • 0742272008 scopus 로고    scopus 로고
    • Developmental pharmacokinetics of morphine and its metabolites in neonates, infants and young children
    • DOI 10.1093/bja/aeh042
    • Bouwmeester NJ, Anderson BJ, Tibboel D, Holford NH. Developmental pharmacokinetics of morphine and its metabolites in neonates, infants and young children. Br. J. Anaesth. 92, 208-217 (2004). (Pubitemid 38159658)
    • (2004) British Journal of Anaesthesia , vol.92 , Issue.2 , pp. 208-217
    • Bouwmeester, N.J.1    Anderson, B.J.2    Tibboel, D.3    Holford, N.H.G.4
  • 59
    • 67649415182 scopus 로고    scopus 로고
    • Mechanistic basis of using body size and maturation to predict clearance in humans
    • Anderson BJ, Holford NH. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab. Pharmacokinet. 24, 25-36 (2009).
    • (2009) Drug Metab. Pharmacokinet. , vol.24 , pp. 25-36
    • Anderson, B.J.1    Holford, N.H.2
  • 60
    • 0141791117 scopus 로고    scopus 로고
    • The development of drug metabolising enzymes and their influence on the susceptibility to adverse drug reactions in children
    • Johnson TN. The development of drug metabolising enzymes and their influence on the susceptibility to adverse drug reactions in children. Toxicology 192, 37-48 (2003).
    • (2003) Toxicology , vol.192 , pp. 37-48
    • Johnson, T.N.1
  • 61
    • 55549143695 scopus 로고    scopus 로고
    • Intestinal metabolism and transport of drugs in children: The effects of age and disease
    • Johnson TN, 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
  • 62
    • 33746829030 scopus 로고    scopus 로고
    • Prediction of metabolic drug clearance in humans: In vitro-in vivo extrapolation vs allometric scaling
    • DOI 10.1080/00498250600761662, PII N6013836140J608T
    • Shiran MR, Proctor NJ, Howgate EM, Rowland-Yeo K, Tucker GT, Rostami- Hodjegan A. Prediction of metabolic drug clearance in humans: in vitro-in vivo extrapolation vs allometric scaling. Xenobiotica 36, 567-580 (2006). (Pubitemid 44174445)
    • (2006) Xenobiotica , vol.36 , Issue.7 , pp. 567-580
    • Shiran, M.R.1    Proctor, N.J.2    Howgate, E.M.3    Rowland-Yeo, K.4    Tucker, G.T.5    Rostami-Hodjegan, A.6
  • 64
    • 70549102005 scopus 로고    scopus 로고
    • Accessed 30 April 2009
    • US FDA. Pediatric drug development. 2009 www.fda.gov/cder/pediatric/ index.htm (Accessed 30 April 2009)
    • (2009) Pediatric Drug Development


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.