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Thursday, June 21, 2007

Pharmacokinetic-Pharmacodynamic Modeling and Simulation

At present, population pharmacokinetics has taken off with an exponential increase in published papers in the last decade. It is fair to say that population pharmacokinetics has revolutionized how data from clinical studies is analyzed. Population pharmacokinetics methods are used almost exclusively for phase II and III studies and to summarize data across a drug development program. Advances in pharmacokinetic and pharmacodynamic modeling will allow fewer, more focused and informative clinical trials, and lead to significant cost savings. Surprisingly, however, despite these advances, population methods are not routinely taught at the graduate level, and pharmaceutical companies still have difficulty recruiting individuals with population pharmacokinetics experience. A major hindrance to implementing population methods is that it is mathematically and statistically complex, and compared to the number of pharmacokineticists in general there are few modelers who specialize in the methodology. A newcomer can read the literature as a source to learn about population pharmacokinetics. But even this task can be difficult because few papers and books published on pharmacokinetics cover the principles of nonlinear mixed effects models. Some books (mainly written by statisticians) have been written on the relevant topics, but these books are not geared toward reading at the outset of learning the material.