Choice of best design

Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective

Volumn , Issue , 2002, Pages 173-200

  Monteleone, Jonathan P R ^a   Duffull, Stephen B ^b  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84859787585     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (65)

1. JJ DiStefano III. Optimized blood sampling protocols and sequential design of kinetic experiments. Am J Physiol 240 (Regulatory Integrative Comparative Physiology, 9):R259-265, 1981.
2. EI Ette, AW Kelman, CA Howie, B Whiting. Interpretation of simulation studies for efficient estimation of population pharmacokinetic parameters. Ann Pharmaco-ther 27(9):1034-1039, 1993.
3. EI Ette, H Sun, TM Ludden. Design of Population Pharmacokinetic Studies. Proceedings of American Statistical Association (Biopharmaceutics Section):487-492, 1994.
4. EM Landau. Optimal design for individual parameter estimation in Pharmacokinetics. In: Rowland M, Sheiner LB, Steimer J, eds. Variability in Drug Therapy— Description, Estimation, and Control: A Sandoz Workshop. New York: Raven Press, 1985, pp 187-200.
5. DZ D’Argenio. Optimal sampling times for pharmacokinetic experiments. Journal Pharmacokinetics & Biopharmaceutics 9(6):739-756, 1981.
6. DZ D’Argenio. Incorporating prior parameter uncertainty in the design of sampling schedules for pharmacokinetic parameter estimation experiments. Math Biosci 99: 105-118, 1990.
7. GL Drusano, A Forrest, KI Plaisance, JC Wade. A prospective evaluation of optimal sampling theory in the determination of the steady-state pharmacokinetics of piperacillin in febrile neutropenic cancer patients. Clin Pharmacol Ther 45(6):635-641, 1989.
8. GL Drusano, A Forrest, MJ Snyder, MD Reed, JL Blumer. An evaluation of optimal sampling strategy and adaptive study design. Clin Pharmacol Ther 44(2):232-238, 1988.
9. PHL Chen. A two-stage design for comparing clinical trials. Biometrical J 34(1): 29-35, 1992.
10. JG Fadel. Simulation of traditional and optimal sampling schedule designs for digestion and passage models. J Theor Biol 157(1):109-126, 1992.
11. LG Ensign, EA Gehan, DS Kamen, PF Thall. An optimal three-stage design for phase II clinical trials. Statistics in Medicine 13(17):1727-1736, 1994.
12. KC Carriere. Crossover designs for clinical trials. Statistics in Medicine 13(10): 1063-1069, 1994.
13. Y Merle, F Mentre. Bayesian design criteria: computation, comparison, and application to a pharmacokinetic and a pharmacodynamic model. J Pharmacokinetics & Biopharmaceutics 23(1):101-125, 1995.
14. RA Markus, J Frank, S Groshen, SP Azen. An alternative approach to the optimal design of an LD50 bioassay. Statistics in Medicine 14(8):841-852, 1995.
15. FY Bois, TJ Smith, A Gelman, HY Chang, AE Smith. Optimal design for a study of butadiene toxicokinetics in humans. Toxicol Sci 49(2):213-224, 1999.
16. P Muller. Simulation Based Optimal Design. In: Berger JO, Bernardo JM, Dawid AP, Smith AFM, eds. Bayesian Statistics. Oxford University Press, 1999.
17. S Duffull, F Mentre, L Aarons. Optimal design of a population pharmacodynamic experiment for ivabradine. Pharm Res 18(1):83-89, 2001.
18. LB Sheiner. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 61(3):275-291, 1997.
19. VV Fedorov. Theory of Optimal Experiments. New York: Academic Press, 1972.
20. AC Atkinson. Recent developments in the methods of optimum and related experimental designs. International Statistical Review 56(2):99-115, 1988.
21. E Walter, L Pronzato. Qualitative and quantitative experiment design for phenomenological models—a survey. Automatica 26(2):195-213, 1990.
22. GEP Box, HL Lucas. Design of experiments in non-linear situations. Biometrika 46:77-90, 1959.
23. R Gieschke, BG Reigner, J-L Steimer. Exploring clinical study design by computer simulation based on pharmacokinetic/pharmacodynamic modelling. Int J Clin Pharmacol Ther 35(10):469-474, 1997.
24. N Holford, H Kimko, J Monteleone, C Peck. Simulation of Clinical Trials. Annu Rev Pharmacol Toxicol 40:209-234, 2000.
25. MK Al-Banna, AW Kelman, B Whiting. Experimental design and efficient parameter estimation in population pharmacokinetics. J Pharmacokinet Biopharm 18(4): 347-360, 1990.
26. PID Lee. Design and power of a population pharmacokinetic study. Pharm Res 18(1):75-82, 2001.
27. N Holford, M Hale, H Ko, J-L Steimer, L Sheiner, C Peck. Simulation in drug development: good practices 1999. http://cdds.georgetown.edu/SDDGP.html
28. DW Taylor, EG Bosch. CTS: a clinical trials simulator. Statistics in Medicine 9(7): 787-801, 1990.
29. I StatSoft. Experimental Design (Industrial DOE), 1997. http://www.ic.polyu.edu.hk/posh97/general/Download/Statistics_textbook/stexdes.html
30. M Hale, WR Gillespie, SK Gupta, B Tuk, NH Holford. Clinical trial simulation— streamlining your drug development process. Applied Clinical Trials 5(8):35-40, 1996.
31. CC Peck, RE Desjardins. Simulation of clinical trials: encouragement and cautions. Applied Clinical Trials 5:31-32, 1996.
32. R Krall, K Engleman, H Ko, C Peck. Clinical trial modeling and simulation—work in progress. Drug Inf J 32(4):971-976, 1998.
33. CC Peck. Drug development: improving the process. Food Drug Law J 52(2):163-167, 1997.
34. DD Breimer, M Danhof. Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development—the “wooden shoe” paradigm. Clin Pharmacokinet 32(4):259-267, 1997.
35. KJ Watling, RA Milius, M Williams. Recent advances in drug discovery. RBI neurotransmissions. Newsletter for the Neuroscientist, Nov.:1-5, 1997.
36. Pharsight Corporation. Knowledge-Accelerated Drug Development. San Francisco: Pharsight Corporation, 1999.
37. L Lesko, M Rowland, C Peck, T Blaschke. Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans. Pharm Res 17(11):1335-1344, 2000.
38. DZ D’Argenio, K Khakmahd. Adaptive control of theophylline therapy: importance of blood sampling times. J Pharmacokin Biopharm 11(5):547-559, 1983.
39. L Endrenyi. Design of Experiments for Estimating Enzyme and Pharmacokinetic Parameters. New York: Plenum Press, 1981.
40. HJ Rostami. Experimental design for pharmacokinetic modeling. Drug Inf J 24:299-313, 1990.
41. E Walter, L Pronzato. Optimal experimental design for nonlinear models subject to large uncertainties. American Journal of Physiology (Regulatory Integrative Comparative Physiology) 253(22):R530-R534, 1987.
42. L Lacey, A Dunne. The design of pharmacokinetic experiments for model discrimination. J Pharmacokinet Biopharm 12(3):351-365, 1984.
43. L Sheiner, J-L Steimer. Pharmacokinetic/pharmacodynamic modeling in drug development. Annu Rev Pharmacol Toxicol 40:67-95, 2000.
44. JW Mandema, D Verotta, LB Sheiner. Building population pharmacokinetic—pharmacodynamic models. I. Models for covariate effects. J Pharmacokin Biopharm 20(5):511-528, 1992.
45. M Karlsson, E Jonsson, C Wilste, J Wade. Assumption testing in population pharmacokinetic models: illustrated with an analysis of moxonidine data from congestive heart failure patients. J Pharmacokin Biopharm 26:207-246, 1998.
46. F Mentre, A Mallet, D Baccar. Optimal design in random-effects regression models. Biometrika 84(2):429-442, 1997.
47. NR Draper, WG Hunter. The use of prior distributions in the design of experiments for parameter estimation in non-linear situations. Biometrika 54:147-153, 1967.
48. J Wakefield, A Racine-Poon. An application of Bayesian population pharmacokinetic-pharmacodynamic models to dose recommendation. Statistics in Medicine 14(9-10):971-986, 1995.
49. Y Merle, F Mentre, A Mallet, AH Aurengo. Designing an optimal experiment for Bayesian estimation: application to the kinetics of iodine thyroid uptake. Statistics in Medicine 30 13(2):185-196, 1994.
50. LB Sheiner, SL Beal. Evaluation of methods for estimating population pharmacokinetic parameters. III. Monoexponential model: routine clinical pharmacokinetic data. J Pharmacokin Biopharm 11(3):303-319, 1983.
51. BL Sheiner, SL Beal. Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data. J Pharmacokin Biopharm 9(5):635-651, 1981.
52. LB Sheiner, SL Beal. Evaluation of methods for estimating population pharmacokinetics parameters. I. Michaelis-Menten model: routine clinical pharmacokinetic data. J Pharmacokin Biopharm 8(6):553-571, 1980.
53. EI Ette, H Sun. Sample size and population pharmacokinetic parameter estimation. Clin Pharmacol Ther 57(2):188, 1995.
54. EN Jonsson, JR Wade, MO Karlsson. Comparison of some practical sampling strategies for population pharmacokinetic studies. J Pharmacokin Biopharm 24(2):245-263, 1996.
55. MO Karlsson, LB Sheiner. The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokin Biopharm 21(6):735-750, 1993.
56. DM Steinberg, WG Hunter. Experimental design: review and comment. Technometrics 26(2):71-97, 1984.
57. J Gabrielsson, D Weiner. Pharmarcokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, 2nd ed. Stockholm: The Swedish Pharmaceutical Press, 1997.
58. EM Landau. Optimal experimental design for biologic compartmental systems with application to pharmacokinetics. (Ph.D. dissertation), University of California at Los Angeles, 1980.
59. F Pukelsheim. Optimal Design of Experiments. New York: Wiley-Interscience, 1993.
60. LB Sheiner, SL Beal. Some suggestions for measuring predictive performance. J Pharmacokin Biopharm 9(4):503-512, 1981.
61. GL Gaile, CJ Willmott. Spatial Statistics and Models. Boston: D. Reidel Publishing Company, 1984.
62. R Amstein, J Steimer, N Holford, T Guentert, A Racine, D Gasser, C Peck, S Kutz-era, H Rohr, F Buehler. RIDO: Multimedia CD-ROM software for training in drug development via PK/PD principles and simulation of clinical trials. Pharm Res 13: S452, 1996.
63. Pharsight Corporation. Pharsight Trial Designer User’s Guide. In. 1.0.0 ed. Palo Alto, California: Pharsight Corporation; 1997.
64. D Bourne. PharmPK LISTSERV, 2001. http://www.boomer.org/pkin
65. H Arsham. Modeling and Simulation, 1999. http://ubmail.ubalt.edu/~harsham/simulation/sim.htm