POPULATION PHARMACOKINETICS OF ANTIRETROVIRAL AGENTS: AN OVERVIEW

Abstract

Despite significant advances in Highly Active Antiretroviral Therapy (HAART) during the past few years, challenges like virologic and/or immunologic failures, adverse effects of medications; drug-drug interactions, viral resistance and dosage individualization still pose significant obstacles to successful treatment. In population pharmacokinetic model, parameter values are reasonably estimated and concentrations of a drug predicted at any time during a dosage regimen in an individual with a set of characteristics such as demographics, abnormal lab parameters and disease state whose effects on drug disposition are accounted for by the model equations. This pharmacokinetic information is used to extrapolate the safety and efficacy findings to the wider patient population who may receive the New Chemical Entity in question. Today, Population Pharmacokinetic analyses are a regular part of the documentation of a New Chemical Entity (NCE). The results from Population analyses are most frequently used to characterize the pharmacokinetics in the target Population, to provide pharmacokinetic data in special populations and to support dosing recommendations for these populations.