Abstract
Although Pharmacokinetic/pharmacodynamic modeling has been around for decades, it is still in its infancy with respect to the future of its current manifestation. Due to the amount of time and other resources that must be committed for successful development and application of these methods, economic incentives must be made available to academic and industrial scientists through the NIH and FDA, respectively. The long-term returns should more than compensate for the investments in the form of scientific understanding of the concentration-effect relationships as well as more efficient and acceptable NDAs. Could this be the answer to the drug lag in the United States and other countries?