Abstract
The major strength of the population analysis approach is that useful information can be extracted from sparse data using blood samples and pharmacologic monitoring during routine safety and efficacy studies conducted during the development of a drug product. The results of these analyses may lead to integrated pharmacokinetic-pharmacodynamic models that can aid the clinician during the initiation and adjustment of therapeutic regimens. In some cases it may be possible to develop closed-loop control systems that monitor a drug concentration or a response and automatically adjust the drug administration rate. Overall, an increase in the safety and efficiency of drug use can be anticipated.