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The authors discuss different ways in which systemic absorption and pharmacokinetics of drug substances might be examined in preclinical species in order to define a suitable regimen for translation into clinical development. Preclinical pharmacokinetic evaluations are based on the choice of an appropriate dosing schedule, an understanding of the interindividual variation and its associated factors (i.e. age, sex, genetics, etc.), and the potential use of population pharmacokinetics models. These models involve the modeling of serum drug concentration profiles as a function of time and relate the distribution of individual pharmacokinetic parameters to the variability of those parameters within an experimental population. The latter may be estimated from the available literature or using in silico techniques. Preclinical pharmacokinetics models predict drug concentration-time profiles and thus can be used to compare different dosing regimens. More importantly, the model may be used to extrapolate knowledge gained in preclinical studies to other species (humans) and to explore alternative dosing regimens. This review focuses on the current preclinical model for prediction of systemic drug exposure. The authors address the use of preclinical pharmacokinetic data to predict human pharmacokinetics, such as a population pharmacokinetic analysis to predict the pharmacokinetics in the human population, and discuss the related considerations in regard to drug dosing and scheduling. The authors examine human pharmacokinetic data and its integration with in vitro and preclinical data to predict the human pharmacokinetics and design a suitable clinical trial. The authors provide a framework for the development of pharmaceutics studies, from the preclinical stage (prediction of pharmacokinetics) to the clinical stage (prediction of human pharmacokinetics).Jamie H
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Saratov State University of Economics and Finance () is a research university in Saratov, Russia. It was founded in 1912. The official campus of the university is located in the city centre of Saratov.

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In February 1879,

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