Research Catalog

Title

Guide to drug development : a comprehensive review and assessment / Bert Spilker.

Author

Spilker, Bert.

Publication

Philadelphia : Wolters Kluwer Health/Lippincott Williams & Wilkins, [2009], ©2009.

Supplementary Content

Publisher description

Items in the Library & Off-site

Holdings

Details

Description

xviii, 1277 pages : illustrations; 29 cm

Subject

• Drug development
• Drug Design
• Drug Evaluation, Preclinical > methods
• Drug Industry > methods
• Pharmaceutical Preparations

Bibliography (note)

• Includes bibliographical references and index.

Contents

Sect. 1. Introduction and Overview of a Company and the Industry -- 1. Introduction to Drug Development -- 2. Pharmaceutical Industry: Definitions -- 3. The Big Picture -- 4. Standards: Types, Uses, and Issues -- 5. Pharma-think, Academic-think, and Government-think -- 6. Pharma Sense versus Common Sense -- Sect. 2. Basic Principles, Strategies, and Approaches -- 7. Overview of Factors Affecting Drug Discovery -- 8. The Drug Discovery Process -- 9. Golden Rules of Drug Discovery -- 10. The Drug Development Process -- 11. Golden Rules of Drug Development -- 12. Biotechnology -- 13. Extrapolating Animal Safety and Efficacy Data to Humans -- 14. Evaluating and Interpreting Data -- 15. Stimulating Innovation and Increasing Efficiency with the Right Questions, People, Milieu, and Approaches -- 16. A New Paradigm of Drug Development -- 17. Future Environments for Drug Discovery and Development -- Sect. 3. Corporate Organization and Management Issues -- 18. Models of International Operations -- 19. Organization at the Corporate Level -- 20. Corporate Management -- 21. Reducing Pharmaceutical Risk -- 22. Enhancing Communication -- 23. Personnel and Staffing Issues -- 24. Competitive Intelligence -- 25. Conflicts of Interest and Bias -- 26. Crisis Management -- 27. Mergers, Joint Ventures, and Alliances -- 28. Pharmacopolitics -- 29. Institutional Memory -- 30. Differences among Pharmaceutical Companies -- Sect. 4. External Corporate Relationships and Interactions -- 31. Interactions and Relationships between Academicians and Industry -- 32. Investigator-sponsored Research Proposals Submitted to Industry -- 33. Technology Transfer from Academia to Industry -- 34. Interactions between Pharmaceutical Companies -- 35. Interactions with Trade Associations -- 36. Interactions with Legislators and Government Agencies -- 37. Interactions and Relationships with Healthcare Professionals -- 38. Interactions with Patients and the Public -- 39. Patient Package Inserts -- 40. Interactions and Relationships with the Media -- Sect. 5. Research and Development Organization, Management, and Assessments -- 41. Organizing Research and Development -- 42. Managing Research and Development and Avoiding Tangents -- 43. Personnel Issues in Drug Discovery and Development -- 44. Myths about the Pharmaceutical Industry and Drug Development -- 45. Fads and Fashions in Drug Development -- 46. The Many Facets of Reality: Approaches to Issues and Problems -- 47. International Organization and Management -- 48. Project Management: Balancing Line Function and Matrix Approaches -- 49. Choosing the Number and Types of Drugs to Develop -- 50. Choosing Standards for Developing Drugs -- 51. Creating and Using Benchmarks -- 52. Evaluating a Portfolio of Investigational Drug Projects -- 53. Compassionate Use Programs -- 54. Virtual Drug Development -- 55. Developing and Marketing Orphan Drugs for Rare Diseases -- 56. Productivity and Project Success -- 57. Overview of Safety and Risk Management -- 58. Developing Standard Operating Procedures -- Sect. 6. Clinical Activities and Issues -- 59. Introduction to Clinical Trials -- 60. Creating a Clinical Strategy and Development Plan for a New Drug or Indication -- 61. Designing and implementing a Clinical Trial -- 62. Questions to Ask about a Clinical Trial Protocol -- 63. Dose-response Relationships in Clinical Trials -- 64. Collecting and Interpreting Life Events Data in Clinical Trials -- 65. Quality of Life and Pharmacoeconomics in Clinical Trials -- 66. Overview of Phase 4 and Postapproval Clinical Activities -- 67. Phase 4 Trials and Postapproval Pharmacovigilance Methodologies -- 68. Feasibility of Multinational Trials -- 69. Groups that Influence Protocol Design -- 70. Monitoring and Auditing a Clinical Trial -- 71. Electronic Data Collection and E-clinical Trials -- 72. Principles of Patient Recruitment and Retention -- 73. Surrogate Endpoints and Biomarkers -- 74. Contract Research Organizations and Outsourcing Strategies -- 75. Conducting Clinical Trials Efficiently and Rapidly -- 76. Clinical Significance -- 77. Incorporating Benefit-to-risk Determinations in Drug Development -- 78. Interactions between Clinicians and Statisticians for Analysis and Interpretation of Clinical Data -- 79. The Concept of Normalcy -- 80. Recruiting and Training Clinical Investigators -- 81. Human Subject Protection and Ethical Issues in Clinical Trials -- 82. Improving the Standards of Clinical Trial Publications -- 83. Registries and Directories of Clinical Trials, plus Disclosure of Their Results and Archiving Their Data -- 84. Clinical Trials Come of Age -- Sect. 7. Regulatory Affairs Activities and Issues -- 85. Introduction to Regulatory Affairs -- 86. Negotiating and Interacting with Regulatory Agencies -- 87. Learning Which Regulatory Guidances and Standards May Be Modified -- 88. Preparing for and Holding Meetings with Regulatory Agencies -- 89. Food and Drug Administration Advisory Committee Meetings -- 90. Regulatory Applications for Marketing Approval and Global Interactions with Regulators -- 91. Regulatory Strategies in Real-life Product Development -- Sect. 8. Marketing Activities, Issues, and Interactions with Medical Affairs -- 92. Overview of Marketing Activities and Issues -- 93. Corporate Issues Regarding the Medical-Marketing Interface -- 94. Organizational and Staffing Issues Regarding the Medical-Marketing Interface -- 95. Marketing Needs, Wants, and Issues In Developing Drugs -- 96. Joint Medical and Marketing Activities -- 97. Switching Prescription Drugs to Over-the-counter Status -- 98. Costs and Pricing -- 99. Providing Product Information to Healthcare Professionals -- Sect. 9. Functional Activities and Issues -- 100. Information Management -- 101. Selected Statistical Issues -- 102. Data Management -- 103. Toxicology Activities and Issues -- 104. Animal Testing and Animal Welfare -- 105. Pharmacokinetics -- 106. Licensing Activities and Issues -- 107. Technical Development Activities and Issues -- 108. Production Activities and Issues -- 109. Patent Activities and Issues -- 110. Legal Activities and Issues -- 111. Financial Activities and Issues -- Sect. 10. Overview of Current and Future Development -- 112. Poor Development and Corporate Practices: Threats to a Phamaceutical Organization -- 113. Keys for Pharmaceutical and Development Success -- 114. Computet Simulations and Modeling -- 115. The Future of Drug Discovery and Development -- Sect. 11. Case Studies in Clinical Development, Regulatory Affairs, and the Management of Drug Development -- 116. Clinical Case Studies -- 117. Regulatory Affairs Case Studies -- 118. Management of Drug Development Case Studies.

ISBN

• 9780781774246 (alk. paper)
• 0781774241 (alk. paper)

LCCN

2008000008

OCLC

• ocn187289462
• 187289462
• SCSB-8853748

Owning Institutions

Columbia University Libraries