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Volumn 8, Issue 3, 2009, Pages 239-252

Application of optimal design methodologies in clinical pharmacology experiments

Author keywords

Mixed effects modelling; Optimal design; Population fisher information matrix; Population pharmacokinetics; Sampling windows

Indexed keywords

DRUG;

EID: 73349129984     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.354     Document Type: Review
Times cited : (26)

References (77)
  • 3
    • 0031003468 scopus 로고    scopus 로고
    • Learning versus confirming in clinical drug development
    • Sheiner LB. Learning versus confirming in clinical drug development. Clinical Pharmacology and Therapeutics 1997; 61:275-291.
    • (1997) Clinical Pharmacology and Therapeutics , vol.61 , pp. 275-291
    • Sheiner, L.B.1
  • 8
    • 0025836658 scopus 로고
    • Population pharmacokinetics: Theory and practice
    • Aarons L. Population pharmacokinetics: theory and practice. British Journal of Clinical Pharmacology 1991; 32:669-670.
    • (1991) British Journal of Clinical Pharmacology , vol.32 , pp. 669-670
    • Aarons, L.1
  • 11
    • 34250632673 scopus 로고    scopus 로고
    • Introduction of quantitative methods in pharmacology and clinical pharmacology: A historical overview
    • Atkinson Jr AJ, Lalonde RL. Introduction of quantitative methods in pharmacology and clinical pharmacology: a historical overview. Clininical Pharmacology and Therapeutics 2007; 82:3-6.
    • (2007) Clininical Pharmacology and Therapeutics , vol.82 , pp. 3-6
    • Atkinson Jr, A.J.1    Lalonde, R.L.2
  • 14
    • 0000963178 scopus 로고    scopus 로고
    • Optimal design in random-effects regression models
    • Mentré F, Mallet A, Baccar D. Optimal design in random-effects regression models. Biometrika 1997; 84:429-442.
    • (1997) Biometrika , vol.84 , pp. 429-442
    • Mentré, F.1    Mallet, A.2    Baccar, D.3
  • 17
    • 0037278847 scopus 로고    scopus 로고
    • Further developments of the Fisher information matrix in nonlinear mixed effects models with evaluation in population pharmacokinetics
    • Retout S, Mentré F. Further developments of the Fisher information matrix in nonlinear mixed effects models with evaluation in population pharmacokinetics. Journal of Biopharmaceutical Statistics 2003; 13:209-227.
    • (2003) Journal of Biopharmaceutical Statistics , vol.13 , pp. 209-227
    • Retout, S.1    Mentré, F.2
  • 18
    • 12344327791 scopus 로고    scopus 로고
    • Optimal population designs for PK models with serial sampling
    • Gagnon R, Leonov S. Optimal population designs for PK models with serial sampling. Journal of Biopharmaceutical Statistics 2005; 15:143-163.
    • (2005) Journal of Biopharmaceutical Statistics , vol.15 , pp. 143-163
    • Gagnon, R.1    Leonov, S.2
  • 20
    • 33947143568 scopus 로고    scopus 로고
    • A program for individual and population optimal design for univariate and multivariate response pharmacokinetic-pharmacodynamic models
    • Gueorguieva I, Ogungbenro K, Graham G, Glatt S, Aarons L. A program for individual and population optimal design for univariate and multivariate response pharmacokinetic-pharmacodynamic models. Computer Methods and Programs in Biomedicine 2007; 86:51-61.
    • (2007) Computer Methods and Programs in Biomedicine , vol.86 , pp. 51-61
    • Gueorguieva, I.1    Ogungbenro, K.2    Graham, G.3    Glatt, S.4    Aarons, L.5
  • 21
    • 73349118197 scopus 로고    scopus 로고
    • Population design evaluation and optimisation for multiple responses models: Application to the pharmacokinetics of AZT and AZT-TP 2
    • Bazzoli C, Retout S, Mentre F. Population design evaluation and optimisation for multiple responses models: application to the pharmacokinetics of AZT and AZT-TP 2. Fundamental and Clinical Pharmacology 2007; 21:9-9.
    • (2007) Fundamental and Clinical Pharmacology , vol.21 , pp. 9-9
    • Bazzoli, C.1    Retout, S.2    Mentre, F.3
  • 22
    • 0035107001 scopus 로고    scopus 로고
    • Development and implementation of the population Fisher information matrix for the evaluation of population pharmacokinetic designs
    • Retout S, Duffull S, Mentré F. Development and implementation of the population Fisher information matrix for the evaluation of population pharmacokinetic designs. Computer Methods and Programs in Biomedicine 2001; 65:141-151.
    • (2001) Computer Methods and Programs in Biomedicine , vol.65 , pp. 141-151
    • Retout, S.1    Duffull, S.2    Mentré, F.3
  • 23
    • 40449086351 scopus 로고    scopus 로고
    • Incorporating correlation in interindividual variability for the optimal design of multiresponse pharmacokinetic experiments
    • Ogungbenro K, Graham G, Gueorguieva I, Aarons L. Incorporating correlation in interindividual variability for the optimal design of multiresponse pharmacokinetic experiments. Journal of Biopharmaceutical Statistics 2008; 18:342-358.
    • (2008) Journal of Biopharmaceutical Statistics , vol.18 , pp. 342-358
    • Ogungbenro, K.1    Graham, G.2    Gueorguieva, I.3    Aarons, L.4
  • 25
    • 1442336286 scopus 로고    scopus 로고
    • Foracchia M, Hooker A, Vicini P, Ruggeri A. POPED, a software for optimal experiment design in population kinetics. Computer Methods and Programs in Biomedicine 2004; 74:29-46.
    • Foracchia M, Hooker A, Vicini P, Ruggeri A. POPED, a software for optimal experiment design in population kinetics. Computer Methods and Programs in Biomedicine 2004; 74:29-46.
  • 26
    • 33747140841 scopus 로고    scopus 로고
    • Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments
    • Hooker A, Vicini P. Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments. AAPS Journal 2005; 7:E759-E785.
    • (2005) AAPS Journal , vol.7
    • Hooker, A.1    Vicini, P.2
  • 28
    • 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. Journal of Pharmacokinetics and Biopharmaceutics 1992; 20:279-294.
    • (1992) Journal of Pharmacokinetics and Biopharmaceutics , vol.20 , pp. 279-294
    • Wang, J.1    Endrenyi, L.2
  • 30
    • 0027201526 scopus 로고
    • Optimum experimental designs for properties of a compartmental model
    • Atkinson AC, Chaloner K, Herzberg AM, Juritz J. Optimum experimental designs for properties of a compartmental model. Biometrics 1993; 49:325-337.
    • (1993) Biometrics , vol.49 , pp. 325-337
    • Atkinson, A.C.1    Chaloner, K.2    Herzberg, A.M.3    Juritz, J.4
  • 31
    • 0028862831 scopus 로고
    • Bayesian design criteria: Computation, comparison, and application to a pharmacokinetic and a pharmacodynamic model
    • Merle Y, Mentré F. Bayesian design criteria: computation, comparison, and application to a pharmacokinetic and a pharmacodynamic model. Journal of Pharmacokinetics and Biopharmaceutics 1995; 23:101-125.
    • (1995) Journal of Pharmacokinetics and Biopharmaceutics , vol.23 , pp. 101-125
    • Merle, Y.1    Mentré, F.2
  • 32
    • 0031412765 scopus 로고    scopus 로고
    • Comparison of ED, EID, and API criteria for the robust optimization of sampling times in pharmacokinetics
    • Tod M, Rocchisani JM. Comparison of ED, EID, and API criteria for the robust optimization of sampling times in pharmacokinetics. Journal of Pharmacokinetics and Biopharmaceutics 1997; 25:515-537.
    • (1997) Journal of Pharmacokinetics and Biopharmaceutics , vol.25 , pp. 515-537
    • Tod, M.1    Rocchisani, J.M.2
  • 33
    • 0037201007 scopus 로고    scopus 로고
    • Fisher information matrix for non-linear mixed-effects models: Evaluation and application for optimal design of enoxaparin population pharmacokinetics
    • Retout S, Mentré F, Bruno R. Fisher information matrix for non-linear mixed-effects models: evaluation and application for optimal design of enoxaparin population pharmacokinetics. Statistics in Medicine 2002; 21:2623-2639.
    • (2002) Statistics in Medicine , vol.21 , pp. 2623-2639
    • Retout, S.1    Mentré, F.2    Bruno, R.3
  • 35
    • 27144506012 scopus 로고    scopus 로고
    • The use of a modified Fedorov exchange algorithm to optimise sampling times for population pharmacokinetic experiments
    • Ogungbenro K, Graham G, Gueorguieva I, Aarons L. The use of a modified Fedorov exchange algorithm to optimise sampling times for population pharmacokinetic experiments. Computer Methods and Programs in Biomedicine 2005; 80:115-125.
    • (2005) Computer Methods and Programs in Biomedicine , vol.80 , pp. 115-125
    • Ogungbenro, K.1    Graham, G.2    Gueorguieva, I.3    Aarons, L.4
  • 39
    • 0026095849 scopus 로고
    • Designs for population pharmacodynamics: Value of pharmacokinetic data and population analysis
    • Hashimoto Y, Sheiner LB. Designs for population pharmacodynamics: value of pharmacokinetic data and population analysis. Journal of Pharmacokinetics and Biopharmaceutics 1991; 19:333-353.
    • (1991) Journal of Pharmacokinetics and Biopharmaceutics , vol.19 , pp. 333-353
    • Hashimoto, Y.1    Sheiner, L.B.2
  • 40
    • 0036840929 scopus 로고    scopus 로고
    • Information matrices with random regressors. Application to experimental designs
    • Pronzato L. Information matrices with random regressors. Application to experimental designs. Journal of Statistical Planning and Inference 2002; 108:189-200.
    • (2002) Journal of Statistical Planning and Inference , vol.108 , pp. 189-200
    • Pronzato, L.1
  • 41
    • 0035049209 scopus 로고    scopus 로고
    • Optimal design of a population pharmacodynamic experiment for ivabradine
    • Duffull SB, Mentré F, Aarons L. Optimal design of a population pharmacodynamic experiment for ivabradine. Pharmaceutical Research 2001; 18:83-89.
    • (2001) Pharmaceutical Research , vol.18 , pp. 83-89
    • Duffull, S.B.1    Mentré, F.2    Aarons, L.3
  • 42
    • 0038115062 scopus 로고    scopus 로고
    • Development of a dosing strategy for enoxaparin in obese patients
    • Green B, Duffull SB. Development of a dosing strategy for enoxaparin in obese patients. British Journal of Clinical Pharmacology 2003; 56:96-103.
    • (2003) British Journal of Clinical Pharmacology , vol.56 , pp. 96-103
    • Green, B.1    Duffull, S.B.2
  • 43
    • 0038336553 scopus 로고    scopus 로고
    • Prospective evaluation of a D-optimal designed population pharmacokinetic study
    • Green B, Duffull SB. Prospective evaluation of a D-optimal designed population pharmacokinetic study. Journal of Pharmacokinetics and Pharmacodynamics 2003; 30:145-161.
    • (2003) Journal of Pharmacokinetics and Pharmacodynamics , vol.30 , pp. 145-161
    • Green, B.1    Duffull, S.B.2
  • 44
    • 28444436619 scopus 로고    scopus 로고
    • Optimal design for model discrimination and parameter estimation for itraconazole population pharmacokinetics in cystic fibrosis patients
    • Waterhouse TH, Redmann S, Duffull SB, Eccleston JA. Optimal design for model discrimination and parameter estimation for itraconazole population pharmacokinetics in cystic fibrosis patients. Journal of Pharmacokinetics and Pharmacodynamics 2005; 32:521-545.
    • (2005) Journal of Pharmacokinetics and Pharmacodynamics , vol.32 , pp. 521-545
    • Waterhouse, T.H.1    Redmann, S.2    Duffull, S.B.3    Eccleston, J.A.4
  • 46
    • 33947177325 scopus 로고    scopus 로고
    • Optimal blood sampling time windows for parameter estimation in population pharmacokinetic experiments
    • Graham G, Aarons L. Optimal blood sampling time windows for parameter estimation in population pharmacokinetic experiments. Statistics in Medicine 2006; 25:4004-4019.
    • (2006) Statistics in Medicine , vol.25 , pp. 4004-4019
    • Graham, G.1    Aarons, L.2
  • 47
    • 60749101977 scopus 로고    scopus 로고
    • Efficient sampling windows for parameter estimation in mixed-effects models
    • López-Fidalgo J, Rodríguez-Díaz JM, Torsney B eds, Physica-Verlag: Heidelberg
    • Patan M, Bogacka B. Efficient sampling windows for parameter estimation in mixed-effects models. In mODa 8 - Advances in Model-Oriented Design and Analysis, López-Fidalgo J, Rodríguez-Díaz JM, Torsney B (eds). Physica-Verlag: Heidelberg, 2007; 147-155.
    • (2007) mODa 8 - Advances in Model-Oriented Design and Analysis , pp. 147-155
    • Patan, M.1    Bogacka, B.2
  • 49
    • 60749134432 scopus 로고    scopus 로고
    • An effective approach for obtaining optimal sampling windows for population pharmacokinetic experiments
    • submitted
    • Ogungbenro K, Aarons L. An effective approach for obtaining optimal sampling windows for population pharmacokinetic experiments. Journal of Biopharmaceutical Statistics submitted.
    • Journal of Biopharmaceutical Statistics
    • Ogungbenro, K.1    Aarons, L.2
  • 53
    • 0031270537 scopus 로고    scopus 로고
    • Compound D- and D-s-optimum designs for determining the order of a chemical reaction
    • Atkinson AC, Bogacka B. Compound D- and D-s-optimum designs for determining the order of a chemical reaction. Technometrics 1997; 39:347-356.
    • (1997) Technometrics , vol.39 , pp. 347-356
    • Atkinson, A.C.1    Bogacka, B.2
  • 55
    • 34548859570 scopus 로고    scopus 로고
    • Bayesian optimal designs for pharmacokinetic models: Sensitivity to uncertainty
    • Dokoumetzidis A, Aarons L. Bayesian optimal designs for pharmacokinetic models: sensitivity to uncertainty. Journal of Biopharmaceutical Statistics 2007; 17:851-867.
    • (2007) Journal of Biopharmaceutical Statistics , vol.17 , pp. 851-867
    • Dokoumetzidis, A.1    Aarons, L.2
  • 56
    • 0035999631 scopus 로고    scopus 로고
    • Population pharmacokinetics model and limited sampling strategy for intravenous vinorelbine derived from phase I clinical trials
    • Nguyen L, Tranchand B, Puozzo C, Variol P. Population pharmacokinetics model and limited sampling strategy for intravenous vinorelbine derived from phase I clinical trials. British Journal of Clinical Pharmacology 2002; 53:459-468.
    • (2002) British Journal of Clinical Pharmacology , vol.53 , pp. 459-468
    • Nguyen, L.1    Tranchand, B.2    Puozzo, C.3    Variol, P.4
  • 60
    • 0032886815 scopus 로고    scopus 로고
    • Optimal sampling theory: An overview of its application to pharmacokinetic studies in infants and children
    • Reed MD. Optimal sampling theory: an overview of its application to pharmacokinetic studies in infants and children. Pediatrics 1999; 104:627-632.
    • (1999) Pediatrics , vol.104 , pp. 627-632
    • Reed, M.D.1
  • 61
    • 33947429261 scopus 로고    scopus 로고
    • Considerations in the rational design and conduct of phase I/II pediatric clinical trials: Avoiding the problems and pitfalls
    • Abdel-Rahman SM, Reed MD, Wells TG, Kearns GL. Considerations in the rational design and conduct of phase I/II pediatric clinical trials: avoiding the problems and pitfalls. Clinical Pharmacology and Therapeutics 2007; 81:483-494.
    • (2007) Clinical Pharmacology and Therapeutics , vol.81 , pp. 483-494
    • Abdel-Rahman, S.M.1    Reed, M.D.2    Wells, T.G.3    Kearns, G.L.4
  • 62
    • 30444448534 scopus 로고    scopus 로고
    • Population pharmacokinetic studies in pediatrics: Issues in design and analysis
    • Meibohm B, Laer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS Journal 2005; 7.
    • (2005) AAPS Journal , vol.7
    • Meibohm, B.1    Laer, S.2    Panetta, J.C.3    Barrett, J.S.4
  • 63
    • 0242442081 scopus 로고    scopus 로고
    • The importance of pharmacokinetic limited sampling models for childhood cancer drug development
    • Panetta JC, Iacono LC, Adamson PC, Stewart CF. The importance of pharmacokinetic limited sampling models for childhood cancer drug development. Clinical Cancer Research 2003; 9:5068-5077.
    • (2003) Clinical Cancer Research , vol.9 , pp. 5068-5077
    • Panetta, J.C.1    Iacono, L.C.2    Adamson, P.C.3    Stewart, C.F.4
  • 64
    • 0030932272 scopus 로고    scopus 로고
    • A general model for the origin of allometric scaling laws in biology
    • West GB, Brown JH, Enquist BJ. A general model for the origin of allometric scaling laws in biology. Science 1997; 276:122-126.
    • (1997) Science , vol.276 , pp. 122-126
    • West, G.B.1    Brown, J.H.2    Enquist, B.J.3
  • 65
    • 0033522952 scopus 로고    scopus 로고
    • The fourth dimension of life: Fractal geometry and allometric scaling of organisms
    • West GB, Brown JH, Enquist BJ. The fourth dimension of life: fractal geometry and allometric scaling of organisms. Science 1999; 284:1677-1679.
    • (1999) Science , vol.284 , pp. 1677-1679
    • West, G.B.1    Brown, J.H.2    Enquist, B.J.3
  • 66
    • 33746803672 scopus 로고    scopus 로고
    • Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children
    • Johnson TN, Rostami-Hodjegan A, Tucker GT. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clinical Pharmacokinetics 2006; 45:931-956.
    • (2006) Clinical Pharmacokinetics , vol.45 , pp. 931-956
    • Johnson, T.N.1    Rostami-Hodjegan, A.2    Tucker, G.T.3
  • 69
    • 0034953568 scopus 로고    scopus 로고
    • Population pharmacokinetic analysis and optimization of the experimental design for mizolastine solution in children
    • Mentré F, Dubruc C, Thenot JP. Population pharmacokinetic analysis and optimization of the experimental design for mizolastine solution in children. Journal of Pharmacokinetics and Pharmacodynamics 2001; 28:299-319.
    • (2001) Journal of Pharmacokinetics and Pharmacodynamics , vol.28 , pp. 299-319
    • Mentré, F.1    Dubruc, C.2    Thenot, J.P.3
  • 70
    • 0030775524 scopus 로고    scopus 로고
    • Evaluation of a sparse sampling strategy for determining vancomycin pharmacokinetics in preterm neonates: Application of optimal sampling theory
    • Burstein AH, Gal P, Forrest A. Evaluation of a sparse sampling strategy for determining vancomycin pharmacokinetics in preterm neonates: application of optimal sampling theory. Annals of Pharmacotherapy 1997; 31:980-983.
    • (1997) Annals of Pharmacotherapy , vol.31 , pp. 980-983
    • Burstein, A.H.1    Gal, P.2    Forrest, A.3
  • 71
    • 33748777952 scopus 로고    scopus 로고
    • Determination of minimal sampling time points for reliable pharmacokinetic evaluation of recombinant factor VIII - an exploratory population pharmacokinetic analysis in paediatric patients suffering from severe haemophilia
    • Stass H. Determination of minimal sampling time points for reliable pharmacokinetic evaluation of recombinant factor VIII - an exploratory population pharmacokinetic analysis in paediatric patients suffering from severe haemophilia. Haemophilia 2006; 12:50-55.
    • (2006) Haemophilia , vol.12 , pp. 50-55
    • Stass, H.1
  • 72
    • 0033802209 scopus 로고    scopus 로고
    • Limited sampling model for the estimation of pharmacokinetic parameters in children
    • Mahmood I. Limited sampling model for the estimation of pharmacokinetic parameters in children. Therapeutic Drug Monitoring 2000; 22:532-536.
    • (2000) Therapeutic Drug Monitoring , vol.22 , pp. 532-536
    • Mahmood, I.1
  • 73
    • 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. International Journal of Clinical Pharmacology and Therapeutics 2004; 42:240-245.
    • (2004) International Journal of Clinical Pharmacology and Therapeutics , vol.42 , pp. 240-245
    • Mahmood, I.1    Tammara, V.2
  • 75
    • 0036130598 scopus 로고    scopus 로고
    • Development of population pharmacokinetic models and optimal sampling times for ibuprofen tablet and suspension formulations in children with cystic fibrosis
    • Beringer P, Aminimanizani A, Synold T, Scott C. Development of population pharmacokinetic models and optimal sampling times for ibuprofen tablet and suspension formulations in children with cystic fibrosis. Therapeutic Drug Monitoring 2002; 24:315-321.
    • (2002) Therapeutic Drug Monitoring , vol.24 , pp. 315-321
    • Beringer, P.1    Aminimanizani, A.2    Synold, T.3    Scott, C.4
  • 77
    • 0028147335 scopus 로고
    • Designing an optimal experiment for Bayesian estimation: Application to the kinetics of iodine thyroid uptake
    • Merle Y, Mentré F, Mallet A, Aurengo AH. Designing an optimal experiment for Bayesian estimation: application to the kinetics of iodine thyroid uptake. Statistics in Medicine 1994; 13:185-196.
    • (1994) Statistics in Medicine , vol.13 , pp. 185-196
    • Merle, Y.1    Mentré, F.2    Mallet, A.3    Aurengo, A.H.4


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