Process of New Drug Discovery and Development presents a practical methodology and up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace.

Features:

• Provides an in-depth review of new advancements in drug discovery and development
• Compiles expertise from industry specialists who have developed and are utilizing the science and business practices discussed
• Includes a case study of issues faced by a start-up pharmaceutical company
• Discusses the role of CROs in new drug development

Contents

1. Integrated Product Development: From Lead Candidate Selection to Life-Cycle Management
2. Scientific Discoveries Application in New Drug Development
3. Combinatorial Chemistry
4. High-Throughput Screening: Enabling and Influencing the Process of Drug Discovery
5. Pharmacological and Pharmaceutical Profiling: New Trends
6. Cell-Based Analysis of Drug Response Using Moving Optical Gradient Fields
7. Patient-Derived Primary Cells in High-Throughput Differential Anti-Tumor Screens: Let the Patients Be the Guide
8. The Evolving Role of the Caco-2 Cell Model to Estimate Intestinal Absorption Potential and Elucidate Transport Mechanisms
9. The Promise of Metabonomics in Drug Discovery
10. Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA-PWG-PhRMA-DruSafe Workshop
11. Drugs from Molecular Targets for CNS and Neurodegenerative Diseases
12. Safety Pharmacology
13. Nonclinical Drug Safety Assessment
14. Preclinical Genotoxicity Testing-Past, Present and Future
15. Standard Drug Developmental Issues: Updated
16. The Need for Animals in Biomedical Research
17. Defining the Actual Research Approach to the New Drug Substance
18. Pharmaceutics and Compounding Issues in New Drug Development and Marketing
19. Late Stage and Process Development Activities
20. Clinical Development
21. Contract Research Organizations: Role and Function in New Drug Development
22. The Front Lines of Clinical Research: The Industry
23. Horizons for Cancer Chemotherapy (and non-Chemotherapy)
24. Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) Clinical Testing Challenges
25. Regulatory and Legal Issues Affecting Drug Development
26. CTD: The Changing Face of the NDA
27. Electronic Publishing
28. The Important Role of Pharmacists in a Complex Risk Management System
29. Managing the Risks from Medical Product Use by Focusing on Patient Education, Monitoring, and Adverse Event Reporting
30. Liability, Litigation, and Lessons in New Drug Development
31. Problems in the Non-Drug Marketplace
32. Patents and New Product Development in the Pharmaceutical and Biotechnology Industries
33. The Pharmaceutical Revolution: Drug Discovery and Development
34. The Discovery of Rituxan
35. Funding the Birth of a Drug: Lessons from the "Sell" Side
36. Innovations for the Drug Development Pathway: What Is Needed Now

Index

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