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Volumn 32, Issue 3, 1998, Pages 693-710

Population pharmacokinetics and pharmacodynamics: An underutilized resource

Author keywords

Pediatric drug use; Pharmacodynamics; Pharmacostatistics; Population pharmacokinetics; Rational drug dosing

Indexed keywords

CAFFEINE; FLUCONAZOLE; RIVASTIGMINE; TACRINE;

EID: 0031826088     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159803200310     Document Type: Review
Times cited : (40)

References (59)
  • 1
    • 0025836658 scopus 로고
    • Population pharmacokinetics: Theory and practice
    • Aarons L. Population pharmacokinetics: Theory and practice. Br J Clin Pharmacol. 1991;32:669-670.
    • (1991) Br J Clin Pharmacol , vol.32 , pp. 669-670
    • Aarons, L.1
  • 2
    • 0022489531 scopus 로고
    • Population pharmacokinetics: Theory and clinical application
    • Whiting B, Kelman AW, Grevel J. Population pharmacokinetics: Theory and clinical application. Clin Pharmacokinet. 1985;11:387-401.
    • (1985) Clin Pharmacokinet , vol.11 , pp. 387-401
    • Whiting, B.1    Kelman, A.W.2    Grevel, J.3
  • 3
    • 0025755806 scopus 로고
    • An introduction to mixed effect modelling: Concepts, definitions and justification
    • Sheiner LB, Grasela TH. An introduction to mixed effect modelling: concepts, definitions and justification. J Pharmacokinet Biopharm. 1991;Suppl 11S-23S.
    • (1991) J Pharmacokinet Biopharm , Issue.SUPPL.
    • Sheiner, L.B.1    Grasela, T.H.2
  • 4
    • 1642303793 scopus 로고
    • Population pharmacodynamic and drug development
    • van Boxtel CJ, Holford NHG, Danhof M, Eds. London: Elsevier Science
    • Holford NHG, Peck CC. Population pharmacodynamic and drug development. In: van Boxtel CJ, Holford NHG, Danhof M, Eds. The in vivo study of drug action. London: Elsevier Science; 1992.
    • (1992) The in Vivo Study of Drug Action
    • Holford, N.H.G.1    Peck, C.C.2
  • 8
    • 0029807073 scopus 로고    scopus 로고
    • Drug development for infants and children: Rescuing the therapeutic orphan
    • Kearns GL. Drug development for infants and children: Rescuing the therapeutic orphan. Drug Info J. 1996;30:1121-1123.
    • (1996) Drug Info J , vol.30 , pp. 1121-1123
    • Kearns, G.L.1
  • 9
    • 0014244852 scopus 로고
    • Editorial comment: Therapeutic orphans
    • Shirkey H. Editorial comment: Therapeutic orphans. J Pediatr. 1968;72:119-120.
    • (1968) J Pediatr , vol.72 , pp. 119-120
    • Shirkey, H.1
  • 12
    • 0026720072 scopus 로고
    • Pharmacokinetics studies in pediatric patients: Clinical and ethical considerations
    • Kauffman RE, Kearns GL. Pharmacokinetics studies in pediatric patients: Clinical and ethical considerations. Clin Pharmacokinet. 1992;23:10-29.
    • (1992) Clin Pharmacokinet , vol.23 , pp. 10-29
    • Kauffman, R.E.1    Kearns, G.L.2
  • 13
    • 0029803864 scopus 로고    scopus 로고
    • The ontogeny of drug disposition: Focus on drug absorption, distribution, and excretion
    • Reed MD. The ontogeny of drug disposition: Focus on drug absorption, distribution, and excretion. Drug Info J. 1996;30:1129-1134.
    • (1996) Drug Info J , vol.30 , pp. 1129-1134
    • Reed, M.D.1
  • 14
    • 0029828785 scopus 로고    scopus 로고
    • Developmental aspects of drug metabolism in children
    • Leeder JS. Developmental aspects of drug metabolism in children. Drug Info J. 1996;30:1135-1143.
    • (1996) Drug Info J , vol.30 , pp. 1135-1143
    • Leeder, J.S.1
  • 15
    • 0029849222 scopus 로고    scopus 로고
    • FDA center for drug evaluation and research (CDER) pediatric plan and new regulations
    • Roberts R, Maldonado S. FDA center for drug evaluation and research (CDER) pediatric plan and new regulations. Drug Info J. 1996;30:1125-1127.
    • (1996) Drug Info J , vol.30 , pp. 1125-1127
    • Roberts, R.1    Maldonado, S.2
  • 16
    • 3543042686 scopus 로고    scopus 로고
    • Guidance for industry: Population pharmacokinetics
    • September
    • FDA Center for Drug Evaluation and Research. Guidance for industry: Population pharmacokinetics. Draft Guidance, September 1997.
    • (1997) Draft Guidance
  • 17
    • 0028207598 scopus 로고
    • Pediatric labelling requirements: Implications for pharmacokinetic studies
    • Wilson JT, Kearns GL, Murphy D, Yaffe SJ. Pediatric labelling requirements: Implications for pharmacokinetic studies. Clin Pharmacokinet. 1994;26:308-325.
    • (1994) Clin Pharmacokinet , vol.26 , pp. 308-325
    • Wilson, J.T.1    Kearns, G.L.2    Murphy, D.3    Yaffe, S.J.4
  • 18
    • 84993712492 scopus 로고    scopus 로고
    • Population pharmacokinetics and pharmacodynamics: European regulatory experiences
    • Balant LP, Aarons L, Eds. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
    • Wade JR. Population pharmacokinetics and pharmacodynamics: European regulatory experiences. In: Balant LP, Aarons L, Eds. The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research; 1997;48-53.
    • (1997) The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose , pp. 48-53
    • Wade, J.R.1
  • 19
    • 0001629521 scopus 로고    scopus 로고
    • The population approach: FDA experience
    • Aarons L, et al, Eds. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
    • Ette El, Miller R, Gillespie WR, et al. The population approach: FDA experience. In: Aarons L, et al, Eds. The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research; 1997;271-275.
    • (1997) The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose , pp. 271-275
    • Ette, El.1    Miller, R.2    Gillespie, W.R.3
  • 20
    • 3543009143 scopus 로고    scopus 로고
    • CPMP/ICH/378/95 Dose-response information to support drug registration
    • CPMP/ICH/378/95 Dose-response information to support drug registration.
  • 21
    • 3542994030 scopus 로고    scopus 로고
    • CPMP/ICH/379/95 Studies in support of special population: Geriatrics
    • CPMP/ICH/379/95 Studies in support of special population: Geriatrics.
  • 22
    • 3543037771 scopus 로고    scopus 로고
    • CPMP/EWP/560/95 Note for guidance on the Investigation of Drug Interactions
    • CPMP/EWP/560/95 Note for guidance on the Investigation of Drug Interactions.
  • 23
    • 0344413826 scopus 로고    scopus 로고
    • Evaluation of potential drug-drug interactions using the population approach
    • Aarons L, et al., Eds. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
    • Ludden TM. Evaluation of potential drug-drug interactions using the population approach. In: Aarons L, et al., Eds. The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research; 1997;39-46.
    • (1997) The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose , pp. 39-46
    • Ludden, T.M.1
  • 24
    • 3542992846 scopus 로고    scopus 로고
    • CPMP/EWP/462/95 Note for Guidance on Clinical Investigation of Medicinal Products in Children
    • CPMP/EWP/462/95 Note for Guidance on Clinical Investigation of Medicinal Products in Children.
  • 25
    • 3542994675 scopus 로고    scopus 로고
    • CPMP/ICH/289/95 (Step 3) Note for guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data
    • CPMP/ICH/289/95 (Step 3) Note for guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data.
  • 27
    • 0022346784 scopus 로고
    • Neonatal population pharmacokinetics of phenobarbital derived from routine clinical data
    • Grasela TH, Donn SM. Neonatal population pharmacokinetics of phenobarbital derived from routine clinical data. Dev Pharmacol Ther. 1985;8:374-383.
    • (1985) Dev Pharmacol Ther , vol.8 , pp. 374-383
    • Grasela, T.H.1    Donn, S.M.2
  • 28
    • 0004972030 scopus 로고    scopus 로고
    • Recent applications of population pharmacokinetic approach: Pre-marketing and postmarketing
    • Aarons L et al, Eds. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
    • Tanigawara Y. Recent applications of population pharmacokinetic approach: Pre-marketing and postmarketing. Aarons L et al, Eds. The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research; 1997;25-28.
    • (1997) The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose , pp. 25-28
    • Tanigawara, Y.1
  • 29
    • 0028244432 scopus 로고
    • Population approaches in drug development. Report on an expert meeting to discuss population pharmacokinetic/pharmacodynamic software
    • Aarons L, Balant LP, Mentré F, Morselli P, Rowland M, Steimer JL, Vozeh S. Population approaches in drug development. Report on an expert meeting to discuss population pharmacokinetic/pharmacodynamic software. Eur J Clin Pharmacol. 1994;46:389-391.
    • (1994) Eur J Clin Pharmacol , vol.46 , pp. 389-391
    • Aarons, L.1    Balant, L.P.2    Mentré, F.3    Morselli, P.4    Rowland, M.5    Steimer, J.L.6    Vozeh, S.7
  • 30
    • 0027080650 scopus 로고
    • Potential of population pharmacokinetics to reduce the frequency of blood sampling required for estimating kinetic parameters in neonates
    • Collart L, Balschke TF, Boucher F, Prober CG. Potential of population pharmacokinetics to reduce the frequency of blood sampling required for estimating kinetic parameters in neonates. Dev Pharmacol Ther. 1992;18:71-80.
    • (1992) Dev Pharmacol Ther , vol.18 , pp. 71-80
    • Collart, L.1    Balschke, T.F.2    Boucher, F.3    Prober, C.G.4
  • 33
    • 0030915015 scopus 로고    scopus 로고
    • Population pharmacokinetics of intravenous caffeine in neonates with apnea of prematurity
    • Lee TC, Charles BG, Steer P, Flenady V, Shearman A. Population pharmacokinetics of intravenous caffeine in neonates with apnea of prematurity. Clin Pharmacol Ther. 1997;61:628-640.
    • (1997) Clin Pharmacol Ther , vol.61 , pp. 628-640
    • Lee, T.C.1    Charles, B.G.2    Steer, P.3    Flenady, V.4    Shearman, A.5
  • 34
    • 0029986311 scopus 로고    scopus 로고
    • Pharmacokinetics of fluconazole in people with HIV infection; A population analysis
    • McLachlan AJ, Tett SE. Pharmacokinetics of fluconazole in people with HIV infection; A population analysis. Br J Clin Pharmacol. 1996;41:291-298.
    • (1996) Br J Clin Pharmacol , vol.41 , pp. 291-298
    • McLachlan, A.J.1    Tett, S.E.2
  • 35
    • 0029077096 scopus 로고
    • Pharmacokinetics and bio-availability of fluconazole in two groups of males with HIV infection compared with a group of males without HTV infection
    • Tett S, Moore S, Ray J. Pharmacokinetics and bio-availability of fluconazole in two groups of males with HIV infection compared with a group of males without HTV infection. Antimicrob Agents Chemother. 1995;39:1835-1841.
    • (1995) Antimicrob Agents Chemother , vol.39 , pp. 1835-1841
    • Tett, S.1    Moore, S.2    Ray, J.3
  • 36
    • 0028141439 scopus 로고
    • The effect of tacrine and lecithin in Alzheimer's disease. A population pharmacodynamic analysis of five clinical trials
    • Holford NHG, Peace K. The effect of tacrine and lecithin in Alzheimer's disease. A population pharmacodynamic analysis of five clinical trials. Eur J Clin Pharmacol. 1994;47:17-24.
    • (1994) Eur J Clin Pharmacol , vol.47 , pp. 17-24
    • Holford, N.H.G.1    Peace, K.2
  • 37
    • 0026471544 scopus 로고
    • Results and validation of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine
    • Holford NHG, Peace K. Results and validation of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine. Proc Natl Acad Sci USA. 1992;89:11471-11475.
    • (1992) Proc Natl Acad Sci USA , vol.89 , pp. 11471-11475
    • Holford, N.H.G.1    Peace, K.2
  • 38
    • 0002499540 scopus 로고    scopus 로고
    • Population models for Alzheimer's and Parkinson's disease
    • Aarons L, et al, Eds. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
    • Holford NHG. Population models for Alzheimer's and Parkinson's disease. In: Aarons L, et al, Eds. The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research; 1997;93-104.
    • (1997) The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose , pp. 93-104
    • Holford, N.H.G.1
  • 41
    • 0029951494 scopus 로고    scopus 로고
    • Population pharmacokinetics of caffeine in neonates and young infants
    • Thomson AH, Kerr S, Wright S. Population pharmacokinetics of caffeine in neonates and young infants. Ther Drug Monit. 1996;18:245-253.
    • (1996) Ther Drug Monit , vol.18 , pp. 245-253
    • Thomson, A.H.1    Kerr, S.2    Wright, S.3
  • 45
    • 0024496539 scopus 로고
    • Lisinopril population pharmacokinetics in elderly and renal disease patients with hypertension
    • Thomson AH, Kelly JG, Whiting B. Lisinopril population pharmacokinetics in elderly and renal disease patients with hypertension. Br J Clin Pharmacol. 1989;27:57-65.
    • (1989) Br J Clin Pharmacol , vol.27 , pp. 57-65
    • Thomson, A.H.1    Kelly, J.G.2    Whiting, B.3
  • 46
    • 84993818637 scopus 로고    scopus 로고
    • Marimastat in healthy volunteers and patients with cancer
    • Aarons L, et al, Eds. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
    • Thomson AH, Rosario M, Murray LS, Elliot HL. Marimastat in healthy volunteers and patients with cancer. In: Aarons L, et al, Eds. The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research; 1997;287.
    • (1997) The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose , pp. 287
    • Thomson, A.H.1    Rosario, M.2    Murray, L.S.3    Elliot, H.L.4
  • 47
    • 0001798256 scopus 로고    scopus 로고
    • Maternal and fetal clinical pharmacology
    • Speight TM, Holford NHG, Eds. Auckland: ADIS International
    • Theis JGW, Koren G. Maternal and fetal clinical pharmacology. In Speight TM, Holford NHG, Eds. Avery's Drug Treatment. 4th Edition. Auckland: ADIS International; 1997;76-126.
    • (1997) Avery's Drug Treatment. 4th Edition , pp. 76-126
    • Theis, J.G.W.1    Koren, G.2
  • 49
    • 0006856405 scopus 로고    scopus 로고
    • Metabolic variability in populations
    • Aarons L, et al, Eds. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
    • Tucker GT, Rostami-Hodjegan A. Metabolic variability in populations. In Aarons L, et al, Eds. The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research; 1997;9-13.
    • (1997) The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose , pp. 9-13
    • Tucker, G.T.1    Rostami-Hodjegan, A.2
  • 50
    • 0030884335 scopus 로고    scopus 로고
    • The contribution of clinical pharmacology surrogates and models to drug development - A critical appraisal
    • Rolan P. The contribution of clinical pharmacology surrogates and models to drug development - a critical appraisal. Br J Clin Pharmacol. 1997;44:219-225.
    • (1997) Br J Clin Pharmacol , vol.44 , pp. 219-225
    • Rolan, P.1
  • 51
    • 0028784776 scopus 로고
    • The target concentration approach to clinical drug development
    • Holford NHG. The target concentration approach to clinical drug development. Clin Pharmacokinet. 1995;29:287-291.
    • (1995) Clin Pharmacokinet , vol.29 , pp. 287-291
    • Holford, N.H.G.1
  • 52
  • 53
    • 0001899602 scopus 로고    scopus 로고
    • Validation of population pharmacokinetic/pharmacodynamic analyses; Review of proposed approaches
    • Aarons L, et al, Eds. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research
    • Mentré F, Ebelin ME. Validation of population pharmacokinetic/pharmacodynamic analyses; Review of proposed approaches. In Aarons L, et al, Eds. The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose. Brussels: Commission of the European Communities, European Cooperation in the Field of Scientific and Technical Research; 1997;147-160.
    • (1997) The Population Approach: Measuring and Managing Variability in Response, Concentration and Dose , pp. 147-160
    • Mentré, F.1    Ebelin, M.E.2
  • 54
    • 0027092348 scopus 로고
    • A computationally efficient approach for the design of population pharmacokinetic studies
    • Wang J, Endrenyi L. A computationally efficient approach for the design of population pharmacokinetic studies. J Pharmacokinet Biopharm. 1992;20:279-294.
    • (1992) J Pharmacokinet Biopharm , vol.20 , pp. 279-294
    • Wang, J.1    Endrenyi, L.2
  • 55
    • 0019604592 scopus 로고
    • Some suggestions for measuring predictive performance
    • Sheiner LB, Beal SL. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm. 1981;9:503-512.
    • (1981) J Pharmacokinet Biopharm , vol.9 , pp. 503-512
    • Sheiner, L.B.1    Beal, S.L.2
  • 56
    • 0030953226 scopus 로고    scopus 로고
    • Stability and performance of a population pharmacokinetic model
    • Ette EI. Stability and performance of a population pharmacokinetic model. J Clin Pharmacol. 1997;37:486-495.
    • (1997) J Clin Pharmacol , vol.37 , pp. 486-495
    • Ette, E.I.1
  • 57
    • 0029621202 scopus 로고
    • Population pharmacokinetic modelling: The importance of informative graphics
    • Ette E, Ludden TM. Population pharmacokinetic modelling: The importance of informative graphics. Pharm Res. 1995;12:1845-1855.
    • (1995) Pharm Res , vol.12 , pp. 1845-1855
    • Ette, E.1    Ludden, T.M.2
  • 59
    • 0028031207 scopus 로고
    • Interaction between structural, statistical and covariate models in population pharmacokinetic analysis
    • Wade JR, Beal SL, Sambol NC. Interaction between structural, statistical and covariate models in population pharmacokinetic analysis. J Pharmacokinet Biopharm. 1994;22:165-177.
    • (1994) J Pharmacokinet Biopharm , vol.22 , pp. 165-177
    • Wade, J.R.1    Beal, S.L.2    Sambol, N.C.3


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