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.

Contents

1. Changing Perspectives in Drug Development
   • The Evolving Drug Discovery and Development Process
   • Redefining Competition in the Pharmaceutical Industry: A Time for Choice

2. Process Challenges in Drug Development
   • The Impact of Liability and Cost Containment on the Drug Development Process
   • Managing the Overall Portfolio for Successful Discover and Development

3. Pharmaceutical and Formulation Factors
   • Pharmaceutical Issues in Drug Development
   • Novel Drug Delivery Systems

4. Drug Design, Pharmacokinetics, and Toxicology
   • Computer-Aided Drug Design
   • New Approaches to Nonclinical Biodisposition Studies
   • Changes in Pharmacokinetics and Drug Metabolism Responsability in Drug Discovery and Development

5. Chemotherapy
   • Anticancer Drug Development

6. Clinical Studies and the Use of Clinical Research Organizations
   • Clinical Pharmacology in Drug Development: A View to Future Effectiveness
   • Contracting CROs in Your Organization: New Strategies for New Challenges
   • The Role of Clinical Research Organizations in Drug Development

7. European and Japanese Approaches
   • Understanding Drug Development and Registration in Japan
   • Increasing the Effectiveness of Clinical Pathology Testing and its Value to Drug Development in Europe
   • New Marketing Authorization Procedures in the European Union and the Impact on Regulatory Strategy

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