Model based development; Pharmacometrics; Real time data assembly
Indexed keywords
ARTICLE;
ATTITUDE TO CHANGE;
CULTURAL FACTOR;
DATA ANALYSIS;
DECISION MAKING;
DRUG RESEARCH;
HUMAN;
INFORMATION PROCESSING;
ORGANIZATION;
PERFORMANCE;
PERSONNEL MANAGEMENT;
PRACTICE GUIDELINE;
PROCESS DESIGN;
PROCESS DEVELOPMENT;
PROCESS MODEL;
SIMULATION;
STAFF TRAINING;
TEAMWORK;
U.S. Department of Health and Human Services. Washington, DC: Food and Drug Administration
U.S. Department of Health and Human Services. Challenge and Opportunity on the Critical Path to New Medical Products. Washington, DC: Food and Drug Administration; 2004.
Data on file. Cognigen Corporation, 395 Youngs Rd, Buffalo, NY 14221.
6
0024404927
An evaluation of population pharmacokinetics in therapeutic trials Part III. Prospective data collection versus retrospective data assembly
Antal EJ, Grasela TH Jr, Smith RB. An evaluation of population pharmacokinetics in therapeutic trials. Part III. Prospective data collection versus retrospective data assembly. Clin Pharmacol Ther. 1989;46:552-559.
Prospective use of population pharmacokinetics/pharmacodynamics in the development of cisatracurium
Schmith VD, Fiedler-Kelly J, Phillips L, Grasela TH Jr. Prospective use of population pharmacokinetics/pharmacodynamics in the development of cisatracurium. Pharm Res. 1997;14:91-97.
An automated drug concentration screening and quality assurance program for clinical trials
Grasela TH, Antal EJ, Fiedler-Kelly J, et al. An automated drug concentration screening and quality assurance program for clinical trials. Drug Inf J. 1999;33:273-279.