Main 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:

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

5. Microdosing: Pharmacokinetic and Metabolism Data Early in the Drug Development Process

Graham Lappin

6. Metabolite Testing in Drug Development

Angus N. R. Nedderman and Don K. Walker

7. The -Omics in Drug Development

Majid Y. Moridani, Robyn P. Araujo, Caroline H. Johnson, and John C. Lindon

8. Optimal Design of Pharmacokinetic-Pharmacodynamic Studies

Lee-Kien Foo and Stephen B. Duffull

9. Pharmacokinetic Studies in Pregnant Women

Jamie L. Renbarger and David M. Haas

10. Design, Conduct and Analysis of Thorough QT Studies

Tanya Russell, Daniel S. Stein, and David J. Kazierad

11. Contribution of Quantitative Whole-body Autoradioluminography to the Early Selection and Development of Drug Candidates

Alain Schweitzer

12. Pharmacokinetics, Modeling, and Simulation in the Development of Sunitinib Malate: A Case Study

Brett E. Houk and Carlo L. Bello

13. The Clinical Significance of Drug Transporters in Drug Disposition and Drug Interactions

Thomas N. Thompson