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Pharmacokinetic based design of individualized dosage regimens

By Jose Miguel Lainez1, Gary Blau1, Linas Mockus1, Seza Orcun, Rex Reklaitis1

1. Purdue University

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Clinical trials and health care studies generate an enormous amount of data. This data is used by pharmaceutical companies during new drug development processes to characterize patient populations and determine a standardized dosage regimen for new patients. Nevertheless, the knowledge embedded in such data is rarely further exploited for individualized dosing. In most cases, there is a significant difference between the pharmacokinetic profile of patients in a population, yet these differences are not reflected in the standardized dosage regimen. Here, a Bayesian methodology is proposed to individualize dosage regimens by combining the pharmacokinetic data collected from a patient population during clinical trials and additional data coming from a minimal number of serum samples from the new patient. A methodology is also described to suggest the sampling schedule for new patients so as to reduce the number of samples required to obtain well characterized individual pharmacometric parameters. Available pharmacokinetic data for Gabapentin, a therapeutic agent for epilepsy and neuropathic pain, is used to illustrate the concepts underlying the proposed strategy and the benefits of an individualized regimen over a standardized dosage regimen.


Support from the United States National Science Foundation (Grant NSF-CBET-0941302) is gratefully acknowledged.


Laínez, J.M., Blau, G., Mockus, L., Orçun, S., Reklaitis, G., 2011. Industrial & Engineering Chemistry Research, 50, 5114-5130

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Researchers should cite this work as follows:

  • Jose Miguel Lainez; Gary Blau; Linas Mockus; Seza Orcun; Rex Reklaitis (2011), "Pharmacokinetic based design of individualized dosage regimens,"

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