PURPOSE Docetaxel (Taxotere), an important chemotherapeutic agent with shown activity in a broad range of cancers, is being investigated for use in combination therapies and as an antiangiogenic agent. Docetaxel exhibits a complex pharmacologic profile with high interpatient variability. Pharmacokinetic models capable of predicting exposure under various dosing regimens would aid the rational d...

OBJECTIVE To describe the relationship between the pharmacokinetic and pharmacodynamic properties of dapoxetine, a drug specifically developed for treating premature ejaculation (PE). METHODS Data from various stages of the clinical development programme were analysed using validated methods for assessing ejaculatory latency. The clinical characteristics were then compared with the pharmacoki...

A powerful new software concept to physiologically based pharmacokinetic (PBPK) modelling of drug disposition is presented. It links the inherent modular understanding in pharmacology with orthogonal design principles from software engineering. This concept allows for flexible and user-friendly design of pharmacokinetic whole body models, data analysis, hypotheses testing or extrapolation. The ...

Introduction During the Workshop "Pharmacokinetics: Defining the Dose for Risk Assessment," two panel discussions were held. The first was "Design of Studies to Obtain Pharmacokinetic Data for Risk Assessment." Emil Pfitzer of HoffmannLa Roche, Inc.; James Stevens of Ciba-Geigy Corporation;Penelope FennerCrisp of the U.S. Environmental Protection Agency Pesticides Program; and Daniel Menzel of ...

The aim of bioequivalence studies is the evaluation of bioequivalence of pharmaceutical products. The products are usually two and basic pharmacokinetic parameters such as AUC, C max and t max are used. These studies aim at investigating the “closeness” of the distributions of the pharmacokinetic parameters (responses) for the two products, which is made mainly by comparing the average values o...

Quantitative structure-activity relationships (QSAR) relating biological activity to physiochemical descriptors have been successfully used for a number of years. It is also long recognized that pharmacokinetic parameters may play an important and even determinant role in drug action. This prompted several researchers to focus attention to pharmacokinetic parameters as potential descriptors in ...

Chen, C. 2017. Pharmacokinetic-Pharmacodynamic Evaluations and Experimental Design Recommendations for Preclinical Studies of Anti-tuberculosis Drugs. Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Pharmacy 231. 58 pp. Uppsala: Acta Universitatis Upsaliensis. ISBN 978-91-554-9877-1. Tuberculosis is an ancient infectious disease and a leading cause of death globally...

Although access to antiretroviral therapy (ART) for the treatment of HIV has increased during the last decade, many patients are still in need of treatment. With limited funds to provide ART to millions of patients worldwide, there is a need for alternative ways to scale up ART in resource limited settings. This review provides an overview of pharmacokinetic, safety and efficacy studies of gene...

This article evaluates a novel approach for estimating the pharmacokinetic risks associated with drug interactions in populations. Preclinical pharmacokinetic and metabolism data are analyzed with a stochastic differential equation-based pharmacokinetic model that recognizes that the risks associated with known drug interactions involve deterministic and stochastic components. Specifically, a B...

At a given external dose of an inhaled chemical the internal dose or the amount absorbed into the body varies depending on pulmonary ventilation and other physiological factors. Such variability is of concern in the development of biological indices of occupational exposure to organic solvent vapours. This paper discusses how physiological factors may influence the pharmacokinetic behaviour of ...