Simulation of clinical trials

Annual Review of Pharmacology and Toxicology

Volumn 40, Issue , 2000, Pages 209-234

  Holford, N H G ^a,b   Kimko, H C ^b   Monteleone, J P R ^a   Peck, C C ^b  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Design optimization; Pharmacodynamics; Pharmacokinetics

Indexed keywords

DRUG;

CLINICAL RESEARCH; COMPUTER PROGRAM; COMPUTER SIMULATION; DRUG INDUSTRY; DRUG RESEARCH; PRIORITY JOURNAL; REVIEW;

CLINICAL TRIALS; COMPUTER SIMULATION; HUMANS; RESEARCH DESIGN; SOFTWARE;

EID: 0034074181     PISSN: 03621642     EISSN: None     Source Type: Book Series    
DOI: 10.1146/annurev.pharmtox.40.1.209     Document Type: Review

References (15)

1. Hoover SV, Perry RE 1989. Simulation: A Problem Solving Approach. New York: Addison-Wesley
2. Sheiner LB, Rubin DB. 1995. Intention-to-treat analysis and the goals of clinical trials. Clin. Phannacol. Ther. 57:6-15
3. Holford NHG. 1995. The target concentration approach to clinical drug development. Clin. Pharmacokinet. 29(5): 287-91
4. Kaufmann WJ, Smarr LL. 1993. Supercomputing and the Transformation of Science. New York: Sci. Am.
5. Johnson SCD. 1998. The role of simu lation in the management of research: What can the pharmaceutical industry learn from the aerospace industry? Drug Inf. J. 32(4):961-70
6. Heilman R. 1995. Drug development: history, "overview," and what are GCPs? Qual. Assur. 4(1):75-79
7. Watling KJ, Milius RA, Williams M. 1997. Recent advances in drug discovery. RBI Neurotrans., Nov., pp. 1-5
8. DiMasi JA. 1996. A new look at United States drug development and approval times. Am. J. Ther. 3:1-11
9. Peck CC. 1997. Drug development: improving the process. Food Drug Law J. 52(2):163-67
10. Maxwell C, Domenet JG, Joyce CRR. 1971. Instant experience in clinical trials: a novel aid to teaching by simulation. J. Clin. Pharmacol. 11(5):323-31
11. Marsh BT. 1975. The planning of a clinical trials workshop. Br. J. Clin. Pharmacol. 2(5):455-61
12. Madsen BW, Woodings TL, Ilett KF, Shenfield GM, Potter JM, et al. 1978. Clinical trial experience by simulation: a workshop report. Br. Med. J. 2(6148): 1333-35
13. Bland JM. 1986. Computer simulation of clinical trial as an aid to teaching the concept of statistical significance. Stat. Med. 5:193-97
14. Pocock SJ, Simon R. 1975. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31(1):103-15
15. Jones DR. 1979. Computer simulation as a tool for clinical trial design. Int. J. Bio-Med. Comp. 10:145-50