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

Guide to Drug Development
A Comprehensive Review and Assessment
by Bert Spilker

Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products.

The book covers many topics not discussed in any other book and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards.

Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development.


Section 1

  1. Introduction and Overview of a Company and the Industry
  2. Introduction to Drug Development
  3. Pharmaceutical Industry: Definitions
  4. The Big Picture
  5. Standards: Types, Uses, and Issues
  6. Pharma-think, Academic-think, and Government-think
  7. Pharma Sense versus Common Sense

Section 2

  1. Basic Principles, Strategies, and Approaches
  2. Overview of Factors Affecting Drug Discovery
  3. The Drug Discovery Process
  4. Golden Rules of Drug Discovery
  5. The Drug Development Process
  6. Golden Rules of Drug Development
  7. Biotechnology
  8. Extrapolating Animal Safety and Efficacy Data to Humans
  9. Evaluating and Interpreting Data
  10. Stimulating Innovation and Increasing Efficiency with the Right Questions, People, Milieu, and Approaches
  11. A New Paradigm of Drug Development
  12. Future Environments for Drug Discovery and Development

Section 3

  1. Corporate Organization and Management Issues
  2. Models of International Operations
  3. Organization at the Corporate Level
  4. Corporate Management
  5. Reducing Pharmaceutical Risk
  6. Enhancing Communication
  7. Personnel and Staffing Issues
  8. Competitive Intelligence
  9. Conflicts of Interest and Bias
  10. Crisis Management
  11. Mergers, Joint Ventures, and Alliances
  12. Pharmacopolitics
  13. Institutional Memory
  14. Differences among Pharmaceutical Companies

Section 4

  1. External Corporate Relationships and Interactions
  2. Interactions and Relationships between Academicians and Industry
  3. Investigator-sponsored Research Proposals Submitted to Industry
  4. Technology Transfer from Academia to Industry
  5. Interactions between Pharmaceutical Companies
  6. Interactions with Trade Associations
  7. Interactions with Legislators and Government Agencies
  8. Interactions and Relationships with Healthcare Professionals
  9. Interactions with Patients and the Public
  10. Patient Package Inserts
  11. Interactions and Relationships with the Media

Section 5

  1. Research and Development Organization, Management, and Assessments
  2. Organizing Research and Development
  3. Managing Research and Development and Avoiding Tangents
  4. Personnel Issues in Drug Discovery and Development
  5. Myths about the Pharmaceutical Industry and Drug Development
  6. Fads and Fashions in Drug Development
  7. The Many Facets of Reality: Approaches to Issues and Problems
  8. International Organization and Management
  9. Project Management: Balancing Line Function and Matrix Approaches
  10. Choosing the Number and Types of Drugs to Develop
  11. Choosing Standards for Developing Drugs
  12. Creating and Using Benchmarks
  13. Evaluating a Portfolio of Investigational Drug Projects
  14. Compassionate Use Programs
  15. Virtual Drug Development
  16. Developing and Marketing Orphan Drugs for Rare Diseases
  17. Productivity and Project Success
  18. Overview of Safety and Risk Management
  19. Developing Standard Operating Procedures

Section 6

  1. Clinical Activities and Issues
  2. Introduction to Clinical Trials
  3. Creating a Clinical Strategy and Development Plan for a New Drug or Indication
  4. Designing and Implementing a Clinical Trial
  5. Questions to Ask about a Clinical Trial Protocol
  6. Dose-esponse Relationships in Clinical Trials
  7. Collecting and Interpreting Life Events Data in Clinical Trials
  8. Quality of Life and Pharmacoeconomics in Clinical Trials
  9. Overview of Phase 4 and Postapproval Clinical Activities
  10. Phase 4 Trials and Postapproval Pharmacovigilance Methodologies
  11. Feasibility of Multinational Trials
  12. Groups that Influence Protocol Design
  13. Monitoring and Auditing a Clinical Trial


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Guide to Drug Development
A Comprehensive Review and Assessment
by Bert Spilker

2009 • 299 pages • $224.00 + shipping
Texas residents please add 6.75 % sales tax

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