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.?
Pharmacokinetics in Drug Development focuses on the current development of technological issues facing drug development teams. Topics include the characterization of drug disposition in pregnant subjects, the measurement of arrhythmic potential, tumor growth modeling, and more.
Preface
1.??? Modeling Tumor Growth in Oncology
Peter L. Bonate
2.??? Drug-Drug Interactions: Designing Development Programs and Appropriate Product Labeling
J. Matthew Hutzler, Jack Cook, and Joseph C. Fleishaker
3.??? Modeling the Progression of Disease
Diane R. Mould
4.??? The Use of Dried Blood Spots for Concentration Assessment in Pharmacokinetic Evaluations
Tapan K. Majumdar and Danny R. Howard&ll3"
![Pharmacokinetics in Drug Development Advances and Applications, Volume 3 [Hardcover]](/itemImage/2/4/2/3/2_890030.jpg "Pharmacokinetics in Drug Development Advances and Applications, Volume 3 [Hardcover] xxx")