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.

Contents

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

8. Basic Principles, Strategies, and Approaches
9. Overview of Factors Affecting Drug Discovery
10. The Drug Discovery Process
11. Golden Rules of Drug Discovery
12. The Drug Development Process
13. Golden Rules of Drug Development
14. Biotechnology
15. Extrapolating Animal Safety and Efficacy Data to Humans
16. Evaluating and Interpreting Data
17. Stimulating Innovation and Increasing Efficiency with the Right Questions, People, Milieu, and Approaches
18. A New Paradigm of Drug Development
19. Future Environments for Drug Discovery and Development

Section 3

20. Corporate Organization and Management Issues
21. Models of International Operations
22. Organization at the Corporate Level
23. Corporate Management
24. Reducing Pharmaceutical Risk
25. Enhancing Communication
26. Personnel and Staffing Issues
27. Competitive Intelligence
28. Conflicts of Interest and Bias
29. Crisis Management
30. Mergers, Joint Ventures, and Alliances
31. Pharmacopolitics
32. Institutional Memory
33. Differences among Pharmaceutical Companies

Section 4

34. External Corporate Relationships and Interactions
35. Interactions and Relationships between Academicians and Industry
36. Investigator-sponsored Research Proposals Submitted to Industry
37. Technology Transfer from Academia to Industry
38. Interactions between Pharmaceutical Companies
39. Interactions with Trade Associations
40. Interactions with Legislators and Government Agencies
41. Interactions and Relationships with Healthcare Professionals
42. Interactions with Patients and the Public
43. Patient Package Inserts
44. Interactions and Relationships with the Media

Section 5

45. Research and Development Organization, Management, and Assessments
46. Organizing Research and Development
47. Managing Research and Development and Avoiding Tangents
48. Personnel Issues in Drug Discovery and Development
49. Myths about the Pharmaceutical Industry and Drug Development
50. Fads and Fashions in Drug Development
51. The Many Facets of Reality: Approaches to Issues and Problems
52. International Organization and Management
53. Project Management: Balancing Line Function and Matrix Approaches
54. Choosing the Number and Types of Drugs to Develop
55. Choosing Standards for Developing Drugs
56. Creating and Using Benchmarks
57. Evaluating a Portfolio of Investigational Drug Projects
58. Compassionate Use Programs
59. Virtual Drug Development
60. Developing and Marketing Orphan Drugs for Rare Diseases
61. Productivity and Project Success
62. Overview of Safety and Risk Management
63. Developing Standard Operating Procedures

Section 6

64. Clinical Activities and Issues
65. Introduction to Clinical Trials
66. Creating a Clinical Strategy and Development Plan for a New Drug or Indication
67. Designing and Implementing a Clinical Trial
68. Questions to Ask about a Clinical Trial Protocol
69. Dose-esponse Relationships in Clinical Trials
70. Collecting and Interpreting Life Events Data in Clinical Trials
71. Quality of Life and Pharmacoeconomics in Clinical Trials
72. Overview of Phase 4 and Postapproval Clinical Activities
73. Phase 4 Trials and Postapproval Pharmacovigilance Methodologies
74. Feasibility of Multinational Trials
75. Groups that Influence Protocol Design
76. Monitoring and Auditing a Clinical Trial

Index

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