Drug and Biological Development

1. Front Matter

   Pages i-xvi

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2. Health Care and Industry Overview and Challenges

   • Ronald P. Evens

   Pages 5-32

3. R&D Planning and Governance

   • Ronald P. Evens, Joel Covinsky

   Pages 33-65

4. R&D Outcomes

   • Ronald P. Evens

   Pages 66-83

5. Discovery and Nonclinical Development

   • Stephen F. Carroll

   Pages 84-106

6. Types of Clinical Studies

   • Lewis J. Smith

   Pages 107-122

7. Metabolism and Pharmacokinetics

   • Jun Shi, Vijay O. Bhargava, Shashank Rohatagi

   Pages 123-147

8. Laws and Regulations: The Discipline of Regulatory Affairs

   • Elaine S. Waller, Nancy L. Kercher

   Pages 148-177

9. Clinical Trial Operations

   • Carl L. Roland, Paul Litka

   Pages 178-201

10. Formulation and Manufacturing

    • Leo Pavliv, James F. Cahill

    Pages 202-221

11. Commercial Division

    • Thomas Lytle

    Pages 222-239

12. Medical Affairs and Professional Services

    • Ronald P. Evens

    Pages 240-274

13. Special Considerations in Research

    • C. Michael White, Jeffrey Kluger, Jessica Song

    Pages 275-350

14. Back Matter

    Pages 351-382

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Ronald P. Evens Editors and Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Editorial Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Chapter/Section Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 This book and CD-ROM contain an extensive discussion of for both public safety and health, industry regulation, and new product development in the pharmaceutical and biotechnol- product approvals. The needs, challenges, and controversies in ogy industries from discovery, to product launch, and through the industry are also addressed throughout the chapters. This life cycle management for the new researcher in academia or book shares how this success and the challenges are acc- industry. The primary goal is the education of new researchers plished by the various groups of specialized people, with all in the academic medical center and industry environments the organization requirements, in compliance with the many about industry-based research and product development. The laws and regulations, and with the many processes and o- perspective is product development (drugs and biologicals) comes necessary from each contributing industry department. especially from the industry situation, along with collabora- This preface and introduction to the book provides a d- tion with medical center scientists. References are quite cussion on the needs and use for the book, brief biographies extensive to support the work, numbering more than 500. The of the editorial board, a brief description of each of the authors collectively have several hundred years of experience authors, acknowledgments, and a list of key information at senior levels in product development in the industry or sources about the industry and related information.

• Biological
• Development
• Drugs
• Evens
• Molecule
• infectious disease
• metabolism

From the reviews:

"‘Drug and Biological Development: From Molecule to Product and Beyond’ covers drug development from portfolio planning through commercialization. The material combines strategic, managerial and operational perspectives. The book is ideal for anyone who wants to understand both the ‘why’ and the ‘how’ of the drug development and commercialization process." (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 4 (5), 2008)

• University of Florida, FL

  Ronald P. Evens

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