The drug development process / edited by Peter G. Welling, Louis Lasagna, Umesh V. Banakar.

Includes bibliographical references and index.

Cover; Half Title; Title Page; Copyright Page; Foreword; Preface; Introduction: Whither Drug Development?; Table of Contents; Contributors; Part I: Changing Perspectives in Drug Development; 1. The Evolving Drug Discovery and Development Process; 2. Redefining Competition in the Pharmaceutical Industry: A Time for Choice; Part II: Process Challenges in Drug Development; 3. The Impact of Liability and Cost Containment on the Drug Development Process; 4. Managing the Overall Portfolio for Successful Discovery and Development; Part III: Pharmaceutical and Formulation Factors. 5. Pharmaceutical Issues in Drug Development6. Novel Drug Delivery Systems; Part IV: Drug Design, Pharmacokinetics, and Toxicology; 7. Computer-Aided Drug Design; 8. New Approaches to Nonclinical Biodisposition Studies; 9. Changes in Pharmacokinetics and Drug Metabolism Responsibility in Drug Discovery and Development; Part V: Chemotherapy; 10. Anticancer Drug Development; Part VI: Clinical Studies and the Use of Clinical Research Organizations; 11. Clinical Pharmacology in Drug Development: A View to Future Effectiveness. 12. Contracting CROs into Your Organization: New Strategies for New Challenges13. The Role of Clinical Research Organizations in Drug Development; Part VII: European and Japanese Approaches; 14. Understanding Drug Development and Registration in Japan; 15. Increasing the Effectiveness of Clinical Pathology Testing and Its Value to Drug Development in Europe; 16. New Marketing Authorization Procedures in the European Union and the Impact on Regulatory Strategy; Index.

"Containing contributions from the many disciplines involved in a drug's evolution, this timely volume examines the entire pharmaceutical development process, emphasizing approaches to increasing efficiency and reducing costs."--Provided by publisher.