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• W35448086 abstract "Optimal drug dose selection through the establishment of exposure–response relationships can improve the safety and efficacy of drugs. These exposure–response relationships can be initially evaluated using in vitro and in vivo systems to help define doses that can be tested in early clinical trials. Unfortunately, data generated from early clinical trials can sometimes lead to selection of suboptimal dosage regimens which can lead to the failure of a potentially active new molecular entity (NME) during Phase III clinical trials. If the NME is successful in Phase III trials and is actively marketed as a drug, the approved dosage regimens may still not be generalizable to a more heterogeneous end-user patient population. As a result, therapeutic drug monitoring is often sought as a mechanism for delivery of personalized medicine in the clinical setting. However, drug-specific assays are often not available for newly marketed drugs, and the ability to define an effect using single-sample concentration–time data is frequently difficult to establish. To overcome this problem, sophisticated mathematical approaches have been developed to integrate exposure–time (pharmacokinetic) with exposure–effect (pharmacodynamics) information. These mathematical approaches include population pharmacokinetic modeling, pharmacokinetic/pharmacodynamic analyses, and Monte Carlo simulation. Population pharmacokinetic analysis leads to the development of a model that can accurately estimate drug exposure using relevant covariates. Pharmacokinetic/pharmacodynamic analyses can then be used to define a target drug exposure associated with a safety or efficacy endpoint. Finally, Monte Carlo simulation can be used to establish the probability for attainment of a specific pharmacodynamic target using the population pharmacokinetic model to test alternative dosage regimens. This integrated approach helps to better define dosage regimens, and allows for the continuous refinement of drug doses at the population and individual levels to improve the safety and efficacy of marketed drugs. This chapter reviews optimal dose selection from an antimicrobial drug perspective. We show how the science of pharmacokinetics/pharmacodynamics has been used to improve the dosing of drugs in “special” patient populations that may not have been evaluated during drug development." @default.
• W35448086 created "2016-06-24" @default.
• W35448086 creator A5031745925 @default.
• W35448086 creator A5042571530 @default.
• W35448086 creator A5084249121 @default.
• W35448086 date "2012-01-01" @default.
• W35448086 modified "2023-09-26" @default.
• W35448086 title "Applications of Pharmacokinetic and Pharmacodynamic Principles to Optimize Drug Dosage Selection" @default.
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