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The optimal dosage regimen for an individual is a combination of dose amount (Dose) and dosing interval (i.e., time between doses), which make the drug level remain in the desired therapeutic window given a target confidence level. The therapeutic window is defined as the concentration range which is below a threshold defining an acceptable risk of toxic side effect (TWU) and above a threshold defining a minimum acceptable level of efficacy (TWL). This tool determines the feasible dosage range for drugs that can be described using a multidose one-compartment model with first order absorption. It takes as input the desired confidence level and dosing interval, and the probability distribution of PK parameter for the patient under study. The tool provides the possibility of describing this probability distribution by using either a collection of samples or a multivariate Gaussian distribution.
Support from the United States National Science Foundation (Grant NSF-CBET-0941302) is gratefully acknowledged.
Lainez, J., Blau, G., Mockus, L., Orcun, S., & Reklaitis, G. (2011). Pharmacokinetic Based Design of Individualized Dosage Regimens Using a Bayesian Approach. Industrial and Engineering Chemistry Research , 50, 5114-5130.
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