Expanding clinical applications of population pharmacodynamic modelling

British Journal of Clinical Pharmacology

Volumn 46, Issue 4, 1998, Pages 321-333

  Minto, Charles ^a,b   Schnider, Thomas ^c  

^a ROYAL NORTH SHORE HOSPITAL   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

^c UNIVERSITY OF BERN   (Switzerland)

Author keywords

Computer simulations; Pharmacodynamics; Population models

Indexed keywords

COMPUTER SIMULATION; DOSE RESPONSE; DRUG DOSE; DRUG METABOLISM; POPULATION MODEL; PRIORITY JOURNAL; REVIEW; STATISTICAL ANALYSIS;

DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; INDIVIDUALITY; MATHEMATICS; MODELS, BIOLOGICAL; PHARMACOKINETICS; PHARMACOLOGY;

EID: 0031691162     PISSN: 03065251     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2125.1998.00792.x     Document Type: Review

References (90)

1. Aarons L. Population pharmacokinetics: theory and practice. Br J Clin Pharmacol 1991; 32: 669-670.
2. Shafer SL, Stanski DR. Improving the clinical utility of anesthetic drug pharmacokinetics. Anesthesiol 1992; 76: 327-330.
3. Shafer SL. Towards optimal intravenous dosing strategies. Seminars in Anesthesia 1993; 12: 222-234.
4. Dayneka NL, Garg V, Jusko WJ. Comparison of four basic models of indirect pharmacodynamic responses. J Pharmacokin Biopharm 1993; 21: 457-478.
5. Jusko WJ, Ko HC. Physiologic indirect response models characterize diverse types of pharmacodynamic effects. Clin Pharmacol Ther 1994; 56: 406-419.
6. Verotta D, Sheiner LB. A general conceptual model for non-steady state pharmacokinetic/pharmacodynamic data. J Pharmacokin Biopharm 1995; 23: 1-4.
7. Sheiner LB, Verotta D. Further notes on physiologic indirect response models. Clin Pharmacol Ther 1995; 58: 238-240.
8. Jusko WJ, Ko HC, Ebling WF. Convergence of direct and indirect pharmacodynamic response models. J Pharmacokin Biopharm 1995; 23: 5-8.
9. Holford NH, Sheiner LB. Understanding the dose-effect relationship: clinical application of pharmacokinetic pharmacodynamic models. Clin Pharmacokinet 1981; 6: 429-453.
10. Segre G. Kinetics of interaction between drugs and biological systems. Il Farmaco 1968; 23: 906-918.
11. Sheiner LB, Stanski DR, Vozeh S, Miller RD, Ham J. Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine. Clin Pharmacol Ther 1979; 25: 358-371.
12. Hull CJ, Van Beem HB, McLeod K, Sibbald A, Watson MJ. A pharmacodynamic model for pancuronium. Br J Anaesth 1978; 50: 1113-1123.
13. Torda TA, Graham G, Warwick NR. The kinetics of effect of neuromuscular blocking drugs. Keio J Med 1994; 43: 27-30.
14. Warwick NR, Graham GG, Torda TA. Pharmacokinetic analysis of the time course of effect of atracurium. Clin Pharmacol Therapeutics 1995; 57: 390-397.
15. Fisher DM, Wright PM. Are plasma concentration values necessary for pharmacodynamic modeling of muscle relaxants? Anesthesiol 1997; 86: 567-575.
16. Shafer SL, Gregg KM. Algorithms to rapidly achieve and maintain stable drug concentrations at the site of drug effect with a computer-controlled infusion pump. J Pharmacokinet Biopharm 1992; 20: 147-169.
17. Henthorn TK, Krejcie TC, Shanks CA, Avram MJ. Time-dependent distribution volume and kinetics of the pharmacodynamic effector site. J Pharm Sci 1992; 81: 1136-1138.
18. Hughes MA, Glass PS, Jacobs JR. Context-sensitive half-time in multicompartment pharmacokinetic models for intravenous anesthetic drugs. Anesthesiol 1992; 76: 334-341.
19. Shafer SL, Varvel JR. Pharmacokinetics, pharmacodynamics, and rational opioid selection. Anesthesiol 1991; 74: 53-63.
20. Sheiner LB. Computer-aided long-term anticoagulation therapy. Computers Biomedical Res 1969; 2: 507-518.
21. Nagashima R, O'Reilly RA, Levy G. Kinetics of pharmacologic effects in man: the anticoagulant action of warfarin. Clin Pharmacol Ther 1969; 10: 22-35.
22. Ludwig EA, Kong AN, Camara DS, Jusko WJ. Pharmacokinetics of methylprednisolone hemisuccinate and methylprednisolone in chronic liver disease. J Clin Pharmacol 1993; 33: 805-810.
23. Lew KH, Ludwig EA, Milad MA, et al. Gender-based effects on methylprednisolone pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 1993; 54: 402-414.
24. Kong AN, Ludwig EA, Slaughter RL, et al. Pharmacokinetics and pharmacodynamic modeling of direct suppression effects of methylprednisolone on serum cortisol and blood histamine in human subjects. Clin Pharmacol Ther 1989; 46: 616-628.
25. Fisher LE, Ludwig EA, Wald JA, Sloan RR, Middleton E Jr, Jusko WJ. Pharmacokinetics and pharmacodynamics of methylprednisolone when administered at 8 am versus 4 pm. Clin Pharmacol Ther 1992; 51: 677-688.
26. Xu ZX, Lee MJ, Slum RA, Jusko WJ. Pharmacodynamic modeling of predmsolone effects on natural killer cell trafficking. Pharmaceutical Res 1995; 12: 459-463.
27. Garg V, Jusko WJ. Pharmacodynamic modeling of nonsteroidal anti-inflammatory drugs: antipyretic effect of ibuprofen. Clin Pharmacol Ther 1994: 55: 87-88.
28. Minto CF, Howe C, Wishart S, Conway AJ, Handelsman DJ. Pharmacokinetics and pharmacodynamics of nandrolone esters in oil vehicle: Effects of ester, injection site and injection volume. J Pharmacol Exp Ther 1997; 281: 93-102.
29. Bouillon T, Meineke I, Port R, Hildebrandt R, Gunther K. Gundert-Remy U. Concentration-effect relationship of the positive chronotropic and hypokalaemic effects of fenoterol in healthy women of childbearing age. Eur J Clin Pharmacol 1996; 51: 153-160.
30. Xu ZX, Sun YN, DuBois DC, Almon RR, Jusko WJ. Third-generation model for corticosteroid pharmacodynamics: roles of glucocorticoid receptor mRNA and tyrosine aminotransferase mRNA in rat liver. J Pharmacokin Biopharm 1995; 23: 163-181.
31. Fattinger KE, Verotta D, Porchet HC:, Munafo A, Le Cotonnec JY, Sheiner LB. Modeling a bivariate control system: LH and testosterone response to the GnRH antagonist amide. Am J Physiol 1996; 271: E775-E787.
32. Holford NH, Peace KE. 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.
33. Shi J, Benowitz NL, Denaro CP, Sheiner LB. Pharmacokinetic-pharmacodynamic modeling of caffeine: tolerance to pressor effects. Clin Pharmacol Ther 1993; 53: 6-14.
34. Porchet HC, Benowitz NL, Sheiner LB. Pharmacodynamic model of tolerance: application to nicotine. J Pharmacol Exp Ther 1988; 244: 231-236.
35. Mandema JW, Wada DR. Pharmacodynamic model for acute tolerance development to the electroencephalographic effects of alfentanil in the rat. J Pharmacol Exp Ther 1995; 275: 1185-1194.
36. Fisher LE, Ludwig EA, Jusko WJ. Pharmacoimmunodynamics of methylprednisolone: trafficking of helper T lymphocytes. J Pharmacokin Biopharm 1992; 20: 319-331.
37. Holford N, Hashimoto Y, Sheiner LB. Time and theophylline concentration help explain the recovery of peak flow following acute airways obstruction. Population analysis of a randomised concentration controlled trial. Clin Pharmacokin 1993; 25: 506-515.
38. Troconiz IF, Sheiner LB, Verotta D. Semiparametric models for antagonistic drug interactions. J Appl Physiol 1994; 76: 2224-2233.
39. Minto CF, Schnilder TW, Egan TD, et al. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I Model development. Anesthesiol 1997; 86: 10-23.
40. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokin Biopharm 1993; 21: 735-750.
41. Mandema JW. Population pharmacokinetics and pharmacodynamics. In Pharmacokinetics, eds Welling PG, Tse FLS. New York, Dekker Marcel, 1995, pp. 411-450.
42. Egan TD, Lemmens HJ, Fiset P, et al. The pharmacokinetics of the new short-acting opioid remifentanil (G187084B) in healthy adult male volunteers. Anesthesiol 1993; 79: 881-892.
43. Kataria BK, Ved SA, Nicodemus HF, et al. The pharmacokinetics of propofol in children using three different data analysis approaches. Anesthesiol 1994; 80: 104-122.
44. Shafer SL, Varvel JR, Aziz N, Scott JC. Pharmacokinetics of fentanyl administered by computer-controlled infusion pump. Anesthesiol 1990; 73: 1091-1102.
45. Dyck JB, Maze M, Haack C, Azarnoff DL, Vuorilehto L, Shafer SL. Computer-controlled infusion of intravenous dexmedetomidine hydrochloride in adult human volunteers. Anesthesiol 1993; 78: 821-828.
46. Schinder TW, Gaeta R, Brose W, Minto CT, Gregg KM, Shafer SL. Derivation and cross-validation of pharmacokinetic parameters for computer-controlled infusion of lidocaine in pain therapy. Anesthesiol 1996; 84: 1043-1050.
47. Bailey JM, Gregg KM. A technique for population pharmacodynamic analysis of concentration-binary response data. Anesthesiol 1997; 86: 825-835.
48. Crowder MJ, Hand DJ. Two-stage linear models; in Cox DR, Hinkley DV, Rubin D, Silverman BW (Ed. by by): Analysis of repeated measures. Chapman & Hall, 1990, pp. 87-99.
49. Neter J, Wasserman W, Kutner MH. Linear regression with one independent variable; in Applied Linear Statistical Models (3rd edn). Irwin, 1990, pp. 23-61.
50. Schnider TW, Minto CF, Bruckert H, Mandema JW. Population pharmacodynamic modeling and covariate detection for central neural blockade. Anesthesiol 1996; 85: 502-512.
51. Karlsson MO, Port RE, Ratain MJ, Sheiner LB. A population model for the leukopenic effect of etoposide. Clin Pharmacol Ther 1995; 57: 325-334.
52. Zeger SL, Liang KY. An overview of methods for the analysis of longitudinal data. Statistics in Med 1992; 11: 1825-1839.
53. Klein JP. Semiparametric estimation of random effects using the Cox model based on the EM algorithm. Biometrics 1992; 48: 795-806.
54. Sheiner LB. A new approach to the analysis of analgesic drug trials, illustrated with bromfenac data. Clin Pharmacol Ther 1994; 56: 309-322.
55. Mandema JW, Stanski DR. Population pharmacodynamic model for ketorolac analgesia. Clin Pharmacol Ther 1996; 60: 619-635.
56. Maitre PO, Buhrer M, Thomson D, Stanski DR. A three-step approach combining Bayesian regression and NONMEM population analysis: application to midazolam. J Pharmacokinet Biopharm 1991; 19: 377-384.
57. Mandema JW, Verotta D, Sheiner LB. Building population pharmacokinetic-pharmacodynamic models. I. Models for covariate effects. J Pharmacokinet Biopharm 1992; 20: 511-528.
58. Wade JR, Beal SL, Sambol NC. Interaction between structural, statistical, and covariate models in population pharmacokinetic analysis. J Pharmacokinet Biopharm 1994; 22: 165-177.
59. Ette EI, Ludden TM. Population pharmacokinetic modeling: the importance of informative graphics. Pharmaceutical Res 1995; 12: 1845-1855.
60. Minto CF, Schnider TW, Shafer SL, Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiol 1997; 86: 24-33.
61. Neter J, Wasserman W, Kutner MH, Diagnostics and Remedial Measures - II; In Applied Linear Statistical Models (3rd edn). IRWIN, 1990, pp. 386-432.
62. Peck CC, Beal SL. Sheiner LB, Nichols AI. Extended least squares nonlinear regression: a possible solution to the 'choice of weights' problem in analysis of individual pharmacokinetic data. J Pharmacokin Biopharm 1984; 12: 545-558.
63. Karlsson MO, Beal SL, Sheiner LB. Three new residual error models for population PK/PD analyses. J Pharmacokin Biopharm 1995; 23: 651-672.
64. Rosner GL, Muller P. Pharmacodynamic analysis of hematologic profiles. J Pharmacokin Biopharm 1994; 22: 499-524.
65. Temple R. Dose response and registration of new drugs. In Dose response relationships in clinical pharmatology eds Lasagna, L, Erill S, Naranjo CA. Elsevier, 1989.
66. Sheiner LB, Rosenberg B, Melmon KL. Modelling of individual pharmacokinetics for computer-aided drug dosage. Computers Biomedical Res 1972; 5: 411-459.
67. Maitre PO, Stanski DR. Bayesian forecasting improves the prediction of intraoperative plasma concentrations of alfentanil. Anesthesiol 1988; 69: 652-659.
68. Kobayashi K, Jodrell DI, Ratain MJ. Pharmacodynamic pharmacokinetic relationships and therapeutic drug monitoring, Cancer Surveys 1993; 17: 51-78.
69. Jodrell DI, Reyno LM, Sridhara R, et al. Suramin: development of a population pharmacokinetic model and its use with intermittent short infusions to control plasma drug concentration in patients with prostate cancer. J Clin Oncol 1994; 12: 166-175.
70. Hoetelmans RM, Burger DM, Meenhorst PL, Beijnen JH. Pharmacokinetic individualisation of zidovudine therapy. Current state of pharmacokinetic-pharmacodynamic relationships. Clin Pharmacokin 1996; 30: 314-327.
71. Maden C, Hopkins SG, Smyser M, Lafferty WE. Survival after AIDS diagnosis in Washington State: trends through 1989 and effect of the case definition change of 1987. J Acquired Immune Deficiency Syndromes 1993; 6: 1157-1161.
72. Lange JM. Current HIV clinical trial design issues. J Acquired Immune Deficiency Syndromes Human Retrovirol 1995; 10 (Suppl 1): S47-S51.
73. Gallard BG, Moyle GJ. Individualisation of HIV therapy: the clinician's perspective. Br J Clin Prac 1995; 49: 145-147.
74. Sheiner LB. The intellectual health of clinical drug evaluation. Clin Pharmacol Ther 1991; 50: 4-9.
75. Sheiner LB, Rubin DB. Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther 1995; 57: 6-15.
76. Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997; 61: 275-291.
77. Vozeh S, Steimer JL, Rowland M, et al. The use of population pharmacokinetics in drug development. Clin Pharmacokin 1996; 30: 81-93.
78. Sheiner LB, Beal SL, Sambol NC. Study designs for dose-ranging. Clin Pharmacol Ther 1989; 46: 63-77.
79. Sheiner LB, Hashimoto Y, Beal SL. A simulation study comparing designs for dose ranging. Stat Med 1991; 10: 303-321.
80. Grasela TH Jr, Antal EJ, Townsend RJ, Smith RB. An evaluation of population pharmacokinetics in therapeutic trials. Part I Comparison methodologies. Clin Pharmacol Ther 1986; 39: 605-612.
81. Grasela TH Jr, Antal EJ, Ereshefsky L, Wells BG, Evans RL, Smith RB. An evaluation of population pharmcokinetics in therapeutic trials. Part II. Detection of a drug-drug interaction. Clin Pharmacol Ther 1987; 42: 433-441.
82. Antal EJ, Grasela TH Jr, Smith RB. An evaluation of population pharmacokinetics in therapeutic trials. Part III. Prospective data collection versus retrospective data assembly. Clin Pharmacol Ther 1989; 46: 552-559.
83. Peck CC, Barr WH, Benet LZ, et al. Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. J Clin Pharmacol 1994; 34: 111-119.
84. Guentert TW, Banken L, Hilton S, Holford NH. Moclobemide: relationships between dose, drug concentration in plasma, and occurrence of adverse events. J Clin Psychopharmacol 1995; 15: 84S-94S.
85. Holford NH, 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: 17-23.
86. Lemmens HJ, Dyck JB, Shafer SL, Stanski DR. Pharmacokinetic-pharmacodynamic modeling in drug development: application to the investigational opioid trefentanil. Clin Pharmacol Ther 1994; 56: 261-271.
87. Lemmens HJ, Egan TD, Fiset P, Stanski DR. Pharmacokinetic/dynamic assessment in drug development: application to the investigational opioid mirfentanil. Anesth Analg 1995; 80: 1206-1211.
88. Reigner BG, Williams PEO, Patel IH, Steimer JL, Peck C, van Brummelen P. An evaluation of the integration of pharmacoknietic and pharmacodynamic principles in clinical drug development. Clin Phamacokinet 1997; 33: 142-152.
89. Samara E, Granneman R. Role of population pharmacokinetics in drug development. A pharmaceutical industry perspective. Clin Pharmacokinet 1997; 32: 294-312.
90. Holford NH, Sheiner LB. Kinetics of pharmacologic response. Pharmacol Ther 1982; 16: 143-166.