Clinical trial simulation (CTS): A regulatory clinical pharmacology perspective

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

Volumn , Issue , 2002, Pages 201-210

  Lee, Peter I D ^a   Lesko, Lawrence J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84968880040     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (9)

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4. Simulation in Drug Development: Good Practices. Washington, DC: Center for Drug Development Sciences, Georgetown University, 1999. http://cdds.georgetown.edu
5. NHG Holford, HC Kimko, JPR Monteleone, CC Peck. Simulation of clinical trials. Annu Rev Pharmacol Toxicol 40:209-234, 2000.
6. M Sale. “Pop PK/PD and simulation in the pharmaceutical industry—survey results, May 2001. Bethesda, MD: FDA/PhRMA Clinical Pharmacology and Drug Metabolism Committee Meeting, May 30, 2001.
7. P Lee. Applications of pharmacokinetics-safety information in regulatory decision making in dose regimen selection for intrinsic/extrinsic factors. Washington, DC: FDA/DIA Sponsored Workshop on Applications of Pharmacokinetics/Safety Information in Drug Development and Regulatory Decisions, April 26, 2001.
8. P Lee. Design and power of a population pharmacokinetic study. Pharmaceutical Research, 18(1):75-82, 2001.
9. FDA website. http://www.fda.gov