Exploring clinical study design by computer simulation based on pharmacokinetic/pharmacodynamic modelling

International Journal of Clinical Pharmacology and Therapeutics

Volumn 35, Issue 10, 1997, Pages 469-474

  Gieschke, R ^a,b   Reigner, B G ^a   Steimer, J L ^a  

^a Pharma Development   (Switzerland)

^b NONE   (Switzerland)

Author keywords

Clinical trial; Computer simulation; Mathematical model; Pharmacodynamics; Pharmacokinetics; Simulation software

Indexed keywords

ANTINEOPLASTIC AGENT;

COMPUTER PROGRAM; COMPUTER SIMULATION; DRUG DESIGN; DRUG EFFICACY; DRUG SAFETY; MATHEMATICAL MODEL; PHARMACODYNAMICS; PHARMACOKINETICS; PREDICTION; REVIEW; SYSTEM ANALYSIS; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS; COMPUTER SIMULATION; HUMANS; MODELS, BIOLOGICAL; MONTE CARLO METHOD; RESEARCH DESIGN; SELECTION BIAS;

EID: 0030814837     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (22)

1. ACSL 1996 ACSL for Windows User's Guide, ACSL. Version 11.4. MCA Software, Concord. MA, USA
2. Amxtein R, Steimer JL. Holford NHG. Guenterl TW. Racine A, Gasser D. Peck C, Kutzera S. Rohr HP, Buehler FR 1996 RIDO: Multimedia CD-Rom software for training in drug developmeni via PK/PD principles and simulation of clinical trials. Pharm Res 13: S452
3. Dayneka NL. Gart V. Jusko WJ 1993 Comparison of four basic models of indirect pharmacodynamic responses. J Pharmacokin Biopharm 21: 457-478
4. Fullerton T. Forrest A, Levy C 1996 Pharmacodynamic analysis of sparse data from concentration- and effect-controlled clinical trials guided by a pilot study. An investigation by simulations. J Pharm Sci 85: 600-607
5. Hale M. Gillespie WR, Gupta SK, Tuk B, Holford NHG 1996 Clinical trial simulation: streamlining your drug development process. Appl Clin Trial 5(8): 35-40
6. Holford NHG, Sheiner LB 1981 Understanding the dosc-effect-rclationship: Clinical applications of pharmacokinetic-pharmacodynamic models. Clin Pharmacokin ft: 429-453
7. ICH 1994 ICH Harmonised Tripartite Guideline: Dose-response information to support drug registration. ICH Secretariat, Geneva
8. Ingram D, Bloch RF 1986 Mathematical methods in medicine. Wiley and Sons, New York, pp 1-32
9. Kaufmann WJ, Smarr LL 1993 Supercomputing and the transformation of science. Scientific American Library, New York
10. MGA 1992 ACSL Beginner's Guide, Edition 10.1. Mitchell and Gauthier Associates, Concord, MA
11. Nowak MA, May AM 1991 Mathematical biology of HIV infections: Antigcnic variation and diversity threshold. Mathematical Bioscicnces 106: 1-21
12. Peck CC, Ban WH, Benet LZ, Collins J, Desjardins RE et al 1992 Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development. Clin Pharmacol Ther 51: 465-473
13. Perkham M, Pinedo H, Umberto V 1995 Oxford Textbook of Oncology. Oxford University Press, Oxford, pp 3-12
14. Pharsight Corporation 1996 Pharsight Trial Designer. Pharsight Corporation, Palo Alto, CA, USA
15. Keener BG, Williams PEO, Patel IH, Steimer JL, Peck C, van Brummelen P 1997 An evaluation of integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Clin Pharma-cokin 33: 142-152
16. Sale M 1996 ACSL BioMed Trialist Toolbox, User Manual Version 1.1. MGA Software, Concord. MA, USA
17. SCI 1996 Clinical Trials Forecaster V1.0. Scientific Consulting. Inc (SCI), Apex, NC, USA
18. Sheiner LB. Stanski DR. Vozeh S. Miller RD, Ham J 1979 Simultaneous modeling of pharmacokinetics and pharmacodynamics: Application to d-tubocurarine. Clin Pharmacol Ther 25: 358-371
19. Sheiner LB, Hashimoto Y, Beal SL 1991 A simulation study comparing designs for dose ranging. Stat Med 10: 303-321
20. Sheiner LB 1997 Learning versus confirming in clinical drug development. Clin Pharmacol Ther 61: 275-291
21. Sieimer JL, Kawai R, Chamick S, Lemarechal MO, Francheteau P. Merdjan H. Sato H 1994 Physiological pharmacokinetic/pharmacodynamic (PB-PK/PD) models in drug development? In: Danhof M, Peck C (eds) 2nd International Symposium on Measurement and Kinetics of In Vivo Drug Effects. Noordwijkerhout, pp 42-47
22. Weinstein CD, McCullough JL 1985 Cell proliferation kinetics. In: Roenigk HH, Maihach HI ted) Psoriasis. Marcel Dekker, New York, pp 233-247