Population Pharmacokinetics: Fundamentals, Methods and Applications

References

• Holford N HG. Parametric Models For the Time Course of Drug Action. The In-Vivo Study of Drug Action. Principles and Applications of Kinetic-Dynamic Modelling, CJ Van Boxel, N HG Holford, M Danhof. Elsevier Science Publications BV. 1992; 61–69
   Google Scholar
• Holford N HG, Sheiner LB. Understanding the Dose-Effect Relationship: Clinical Application of Pharmacokinetic-Pharmacodynamic Models. Clin Pharmacokinet 1981; 6: 429–453
   PubMed Web of Science ®Google Scholar
• Sheiner LB, Stanski DR, Vozeh S, Miller RD, Ham J. Simultaneous Modeling of Pharmacokinetics and Pharmacodynamics: Application To Tubocurarine. Clin Pharmacol Ther 1979; 25: 358–371
   PubMed Web of Science ®Google Scholar
• The In-Vivo Study of Drug Action. Principles and Applications of Kinetic-Dynamic Modelling, CJ Van Boxel, N HG Holford, M Danhof. Elsevier Science Publishers BV. 1992
   Google Scholar
• Whiting B, Kelman AW, Grevel J. Population Pharmacokinetics. Theory and Clinical Application. Clin Pharmacokinet 1986; 11: 387–401
   PubMed Web of Science ®Google Scholar
• Carter AA, Rosenbaum SE, Dudley MN. Review of Methods in Population Pharmacokinetics. Clin Res Regul Affairs 1995, (in press)
   Google Scholar
• Peck CC, D'argenio DZ, Rodman JH. Analysis of Pharmacokinetic Data for Individualizing Drug Dosage Regimens. Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. 3rd Edition, WE Evans, JJ Schentag, WJ Jusko. Applied Therapeutics, Inc., Vancouver, WA 1992
   Google Scholar
• Kataria BK, Ved SA, Nicodemus HF, Hoy GR, Lea D, Dubois MY, Mandama JW, Shafer SL. The pharmacokinetics of propofol in children using three different data analysis approaches. Anesthesiology 1994; 80: 104–122
   PubMed Web of Science ®Google Scholar
• Egan TD, Lemmens H JM, Fiset P, Hermann DJ, Muir KT, Stanski DR, Shafer SL. The pharmacokinetics of the new short-acting opiod remifentanil (GI87084B) in healthy adult male volunteers. Anesthesiology 1993; 79: 881–892
   PubMed Web of Science ®Google Scholar
• Gilman TM, Brunnemann SR, Segal JL. Comparison of population pharmacokinetic models for gentamicin in spinal cord-injured and able-bodied patients. Antimicrob. Agents Chemother. 1993; 37: 93–68
   PubMed Web of Science ®Google Scholar
• Dodge WF, Jelliffe RW, Richardson CJ, McCleery RA, Hokanson JA, Snodgrass WR. Gentamicin population pharmacokinetic models for low birth weight infants using a new nonparametric method. Clin. Pharmacol. Ther. 1991; 50: 25–31
   PubMed Web of Science ®Google Scholar
• Sheiner LB, Ludden TM. Population Pharmacokinetics/Dynamics. Annu. Rev. Pharmacol. Toxicol. 1992; 32: 185–209
   PubMed Web of Science ®Google Scholar
• Sheiner LB, Rosenberg B, Marathe VV. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. J. Pharmacokinet. Biopharm. 1977; 5: 445–479
   PubMedGoogle Scholar
• NONMEM User's Guide, AJ Boeckmann, LB Sheiner, SL Beal. NONMEM Project Group, University of California at San Francisco. 1992
   Google Scholar
• Beal SL. 1. Population Pharmacokinetic Data and Parameter Estimation Based on Their First Two Statistical Moments. Drug Metab. Rev. 1984; 15: 173–193
   PubMed Web of Science ®Google Scholar
• Bruno R, Iliadis M-C, Lacarelle B, Cosson V, Mandema JW, Le Roux Y, Montay G, Durand A, Ballereau M, Alasia M, Albanese J, Francois G, Iliadis A, Frydman A. Evaluation of Bayesian estimation in comparison to NONMEM for population pharmacokinetic data analysis: Application to pefloxacin in intensive care unit patients. J. Pharmacokinet. and Biopharm. 1992; 20: 653–669
   PubMedGoogle Scholar
• Sheiner LB, Beal SL. Evaluation of methods for estimating population pharmacokinetic parameters. III. Monoexponential model: routine clinical pharmacokinetic data. J. Pharmacokinet. Biopharm. 1983; 11: 303–19
   PubMedGoogle Scholar
• Mungall DR, Ludden TM, Marshall J, Hawkins DW, Talbert RT, Crawford MH. Population pharmacokinetics of racemic warfarin in adult patients. J. Pharmacokinet. Biopharm. 1985; 13: 213–227
   PubMedGoogle Scholar
• Yukawa E, Higuchi S, Aoyama T. One-point feedback control method for phenytoin dosage adjustment. J. Pharm. Pharmacol. 1991; 43: 499–503
   PubMed Web of Science ®Google Scholar
• Rodman JH, Silverstein MS. Comparison of two-stage and first-order methods for estimation of population parameters in an intensive pharmacokinetics study. Clin. Pharmacol. Ther. 1990; 47: 151
   Web of Science ®Google Scholar
• White DB, Walawander CA, Tung Y, Grasela TH. An evaluation of point and interval estimates in population pharmacokinetics using NONMEM analysis. J. Pharmacokinet. Biopharm. 1991; 19: 87–112
   PubMedGoogle Scholar
• Mallet A. A maximum likelihood estimation methods for random coefficient regression models. Biometrika 1986; 73: 645–56
   Web of Science ®Google Scholar
• Mallet A, Mentre F, Steimer J-L, Lokiec F. Nonparametric maximum likelihood for population pharmacokinetics, with application to cyclosporine. J. Pharmacokinet. Biopharm. 1988; 16: 311–327
   PubMedGoogle Scholar
• Jelliffe RW, Gomis P, Schumitzky A. A population model of gentamicin made with a new nonparametric EM algorithm. Laboratory for Applied Pharmacokinetics, USC School of Medicine, Los Angeles, CA, Technical Report 90-4
   Google Scholar
• Aarons L. The estimation of population pharmacokinetic parameters using and EM algorithm. Comp. Meth. Prog. Biomed. 1993; 41: 9–16
   PubMed Web of Science ®Google Scholar
• Jelliffe RW, Schumitzky A, Van Guilder M. User Manual for The Non-Parametric EM Program for Population Pharmacokinetic Modeling version 2.17. Laboratory for Applied Pharmacokinetics, USC School of Medicine, Los Angeles, CA December 15, 1993
   Google Scholar
• Kisor DF, Watling SM, Zarowitz BJ, Jelliffe RW. Population pharmacokinetics of gentamicin. Use of the nonparametric expectation maximization (NPEM) algorithm. Clin. Pharmacokinet. 1992; 23: 62–68
   PubMed Web of Science ®Google Scholar
• Davidian M, Gallant AR. Smooth nonparametric maximum likelihood estimation for population pharmacokinetics, with application to quinidine. J. Pharmacokinet. Biopharm. 1992; 20: 529–556
   PubMedGoogle Scholar
• Steimer J-L, Mallet A, Golmard J-L, Boisvieux J-F. Alternative approaches to estimation of population pharmacokinetic parameters: comparison with the nonlinear mixed-effect model. Drug Metab. Rev. 1984; 15: 265–292
   PubMed Web of Science ®Google Scholar
• Forrest A, Ballow CH, Nix DE, Birmingham MC, Schentag JJ. Development of a population pharmacokinetic model and optimal sampling strategy for intravenous ciprofloxacin. Antimicrob. Agents Chemother. 1993; 37: 1065–1072
   PubMed Web of Science ®Google Scholar
• Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring. 3rd Edition, WE Evans, JJ Schentag, WJ Jusko. Applied Therapeutics, Inc., Vancouver, WA 1992
   Google Scholar
• Jelliffe RW, Igelesias T, Hurst A, Foo KA, Rodriguez J. Individualizing Gentamicin Dosage Regimens. A Comparative Review of Selected Models, Data Fitting Methods an Monitoring Strategies. Clin Pharmacokinet 1991; 21: 461–478
   PubMed Web of Science ®Google Scholar
• Chiou WL, Gadalla M AF, Pang GW. Method For the Rapid Estimation of the total body clearance and adjustment of dosage regimens in patients during a constant-rate infusion. J Pharmacokin and Biopharm 1978; 6: 135–151
   PubMedGoogle Scholar
• Vozehs, Muir KT, Sheiner LB, Follath F. Predicting individual phenytoin dosage. J Pharmacokin Biopharam 1981; 9: 131–146
   PubMed Web of Science ®Google Scholar
• Sawchuk RJ, Zaske DE. Pharmacokinetics of Dosing Regimens which Utilize Multiple Intravenous Infusions: Gentamicin in Burn Patients. J Pharmacokinet Biopharm 1976; 4: 183–195
   PubMedGoogle Scholar
• Sawchuk RJ, Zaske DE, Cipolle RJ, Wargin WA, Strate RJ. Kinetic Model of Gentamicin Dosing With the Use of Individual Patient Parameters. Clin Pharmacol Therap 1977; 21: 362–369
   PubMed Web of Science ®Google Scholar
• Sheiner LB, Beal SL, Rosenberg B, Marathe VV. Forecasting Individual Pharmacokinetics. Clin Pharmacol Ther 1979; 26: 294–305
   PubMed Web of Science ®Google Scholar
• Buffington DE, Lampasona V, Chandler M HH. Computers in Pharmacokinetics. Choosing Software for Clinical Decision Making. Clin Pharmacokinet 1993; 25: 205–216
   PubMed Web of Science ®Google Scholar
• Thomson AH, Whiting B. Bayesian Parameter Estimation and Population Pharmacokinetics. Clin Pharmacokinet 1992; 22: 447–467
   PubMed Web of Science ®Google Scholar
• Higuchi S, Yukawa E, Aoyama T. Bayesian Prediction of Serum Phenytoin Concentration in a Simulation Study. Chemical Pharmaceut Bull 1988; 36: 1914–1918
   PubMed Web of Science ®Google Scholar
• Rodman JH, Relling MV, Stewart CF, Synold TW, McLeod H, Kearns C, Stute N, Crom W, Evans WE. Clinical Pharmacokinetics and Pharmacodynamics of Anticancer Drugs in Children. Seminars in Oncol 1993; 20: 18–29
   PubMed Web of Science ®Google Scholar
• Jelliffe RW, Schumitzky A, Van Guilder M, Liu Hu M.L, Maire P, Gomis P, Barbaut X, Tahani B. Individualizing Drug Dosage Regimens: Roles of Population Pharmacokinetic and Dynamic Models, Bayesian Fitting and Adaptive Control. Therap Drug Monitor 1993; 15: 380–393
   PubMed Web of Science ®Google Scholar
• Inciardi JF, Batra KK. Nonparametric Approach to Population Pharmacokinetics in Oncology Patients Receiving Aminoglycoside Therapy. Antimicrobial Agents Chemotherapy 1993; 37: 1025–1027
   PubMed Web of Science ®Google Scholar
• Watling SM, Kisor DF. Population Pharmacokinetics: Development of a Medical Intensive Care Unit-Specific Gentamicin Dosing Nomogram. Annals Pharmacother 1993; 27: 151–154
   PubMed Web of Science ®Google Scholar
• Bayard DS, Milam MH, Schumitzky. Design of Dosage Regimens: A Multiple Model Stochastic Control Approach. University of Southern California School of Medicine, Laboratory of Applied Pharmacokinetics, Technical Report 92-1
   Google Scholar
• Peck CC, Barr WH, Benet LZ, et al. Opportunities For Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development. Clin Pharmacol Ther 1992; 51: 465–473
   PubMed Web of Science ®Google Scholar
• Steimer J-L, Ebelin M-E, Van Bree J. Pharmacokinetic and Pharmacodynamic Data and Models In Clinical Trials. Eur J Drug Met Pharmacokinet 1993; 18: 61–76
   PubMed Web of Science ®Google Scholar
• Balant LP, Roseboom H, Gundert-Remy UM. Pharmacokinetic Criteria For Drug Research and Development. Adv Drug Res 1990; 19: 1–138
   Google Scholar
• Shah RR. Clinical Pharmacokinetics: Current Requirements and Future Perspectives From a Regulatory Point of View. Xenobiotica 1993; 23: 1159–1193
   PubMed Web of Science ®Google Scholar
• Van Peer A, Snoeck E, Huang M-L, Heykants J. Pharmacokinetic-Pharmacodynamic Relationships In Phase I/Phase II of Drug Development. Eur J Drug Metab Pharmacokinet 1993; 18: 49–59
   PubMed Web of Science ®Google Scholar
• Sanathanan LP, Peck CC. The Randomized Concentration-Controlled Trial: An Evaluation of Its Sample Size Efficiency. Controlled Clin Trial 1991; 12: 780–794
   PubMedGoogle Scholar
• Levy G, Ebling WF, Forrest A. Concentration- or Effect- Controlled Clinical Trials With Sparse Data. Clin Pharmacol Ther 1994; 56: 1–8
   PubMed Web of Science ®Google Scholar
• Endrenyi L, Zha J. Comparative Efficiencies of Randomized Concentration- and Dose-Controlled Concentration Clinical Trials. Clin Pharmacol Therap 1994; 56: 331–338
   PubMed Web of Science ®Google Scholar
• Levy G. Concentration-Controlled Versus Concentration Defined Clinical Trials. Clin Pharmacol Ther 1993; 53: 385
   PubMed Web of Science ®Google Scholar
• Temple R. The Clinical Investigation of Drug Use in the Elderly. Food and Drug Guidelines. Clin Pharmacol Ther 1987; 42: 681–685
   PubMed Web of Science ®Google Scholar