作者: Kyungsoo Park , David Z. D'Argenio
DOI: 10.1002/9780471740360.EBS1357
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摘要: The use of mathematical modeling and simulation is central to the study absorption, distribution, elimination therapeutic drugs (pharmacokinetics) understanding how produce their effects (pharmacodynamics). From its inception, field pharmacokinetics pharmacodynamics has applied methods modeling, estimation, simulation, experiment design, control in an effort better understand, quantify, regulate processes uptake, disposition, action drugs. These for pharmacokinetic/pharmacodynamic systems analysis impact all aspects drug development including vitro, animal human testing, as well therapy. Systems confront many challenges related part severe restrictions on number type measurements that are available from laboratory experiments clinical trials, variability uncertainty associated with themselves. Accordingly, specialized have been developed address these unique challenges. This chapter focuses processes, which application problems dose regimen design patient therapy (pharmacotherapeutics) trials. After a review field, general framework presented problem presented, followed by discussion enabling computational along example illustrating methods. Keywords: dose design; clinical trials; drug