Drug Development Handbook from C.H.I.P.S.

Process of New Drug Discovery and Development
Second Edition
edited by Charles G. Smith

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.


  • 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


  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


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Process of New Drug Discovery and Development
Second Edition
edited by Charles G. Smith

2006 688 pages $228.95 + shipping
Texas residents please add 6.75 % sales tax

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