Full Description
The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection. Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry.
Contents
Modeling Tumor Growth in Oncology.- Drug-Drug Interactions: Designing Development Programs and Appropriate Product Labeling.- Modeling the Progression of Disease.- The Use of Dried Blood Spots for Concentration Assessment in Pharmacokinetic Evaluations.- Microdosing: Pharmacokinetic and Metabolism Data Early in the Drug Development Process.- Metabolite Testing in Drug Development.- The - Omics in Drug Development.- Optimal Design of Pharmacokinetic-Pharmacodynamic Studies.- Pharmacokinetic Studies in Pregnant Women.- Design, Conduct and Analysis of Thorough QT Studies.- Contribution of Quantitative Whole-body Autoradioluminography to the Early Selection and Development of Drug Candidates.- Pharmacokinetics, Modeling, and Simulation in the Development of Sunitinib Malate: A Case Study.- The Clinical Significance of Drug Transporters in Drug Disposition and Drug Interactions.
