References for Clinical Trial Simulations
Clinical Trial Simulations: Major References
Main publications on clinical trial simulations
Bonate PL (2000). Clinical trial simulation in drug development. Pharmaceutical Research; 17: 252-256.
Holford NHG, Kimko HC, Monteleone JPR and Peck CC (2000). Simulation of clinical trials. Annual Review of Pharmacology and Toxicology; 40: 209-234.
Holford NHG et al. Simulation in drug development: good practices. Internet address http://cdds.georgetown.edu/research/sddgp723.html 1999.
Johnson SCD. The role of simulation in the management of research: what can the pharmaceutical industry learn from the aerospace industry (1998). Drug Information Journal; 32: 961-969.
Kowalski KG and Hutmacher MM (2001). Design evaluation for a population pharmacokinetic study using clinical trial simulation: a case study. Statistics in Medicine; 20: 75-91.
Krall RL et al. (1998). Clinical trial modeling and simulation---work in progress. Drug Information Journal; 32: 971-976.
Peck C and Desjardins R (1996). Simulation of clinical trials-encouragement and cautions. Applied Clinical Trials; 5: 30-32.
Related publications for clinical trial simulations
Rowland M and Tozer TN. Clinical Pharmacokinetics: Concepts and Applications (3rd Edition), Williams & Wilkins, Baltimore, 1995.
Senn S and Hale M. Moving forward: applying computer-assisted trial design to current practices in drug development. Visit Pharsight company at http://www.pharsight.com/ 1997.
Sheiner LB and Steimer J-L (2000). Pharmacokinetic/pharmacodynamic modeling in drug development. Annu. Rev. Pharmacol. Toxicol; 40: 67-95.
Aarons Leon (1999). Software for population pharmacokinetics and pharmacodynamics. Clin Pharmacokinet; 36: 255-264.
Chabaud S et al. (2002). Clinical trial simulation using therapeutic effect modeling: application to ivabradine efficacy in patients with angina pectoris. Journal of Pharmacokinetics and Pharmacodynamics; 29: 339-363.
Veyrat-Follet C, Bruno R, Olivares R et al. (2000). Clinical trial simulation of docetaxel in patients with cancer as a tool for dosage optimization. Clin Pharmacol Ther; 68, 677-687.
Related publications for computer simulations
Craig SM, Goldstein M et al. (2001). Bayesian forecasting for complex systems using computer simulators. JASA; 96: 717-729
Kennedy MC and O'Hagan A (2000). Predicting the output from a complex computer code when fast approximations are available. Biometrika; 87: 1-13.
Kennedy MC and O'Hagan A (2001). Bayesian calibration of computer models (with discussions). J. R. Statist. Soc. B; 63: 425-464.
Poole D and Raftery AE (2000). Inference for deterministic simulation models: the Bayesian melding approach. JASA; 95: 1244-1255.
Sacks J, Welch WJ, Mitchell TJ and Wynn HP (1998). Design and analysis of computer experiments. Statistical Science; 4: 409-435.
Introductory References for Students and New Researchers
Bonate PL (2000). Clinical trial simulation in drug development. Pharmaceutical Research; 17: 252-256.
Holford NHG, Kimko HC, Monteleone JPR and Peck CC (2000). Simulation of clinical trials. Annual Review of Pharmacology and Toxicology; 40: 209-234.
Kowalski KG and Hutmacher MM (2001). Design evaluation for a population pharmacokinetic study using clinical trial simulation: a case study. Statistics in Medicine; 20: 75-91.
Krall RL et al. (1998). Clinical trial modeling and simulation---work in progress. Drug Information Journal; 32: 971-976.
Peck C and Desjardins R (1996). Simulation of clinical trials-encouragement and cautions. Applied Clinical Trials; 5: 30-32.
Kimko H and Duffull SB. Simulation for Designing Clinical Trials. Marce Dekker, 2002.