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Drug and Biological Development

From Molecule to Product and Beyond

  • Textbook
  • © 2007

Overview

Editors:
  1. Ronald P. Evens

    1. University of Florida, FL

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  • No single book employs both a format designed for fellows’ and residents’ education and covers the full scope of drug development from discovery through a product’s life cycle

  • The unique features of this book are several-fold: the dual narrative - slide design, which is a user friendly format for fellows and faculty (book), research controversies being addressed, real life examples being addressed, up-to-date material, general information section for each chapter for non-experts, detail information sections for depth as needed, and expert industry and research authors

  • Extensive and hands-on experiences of the authors and editors in the product development and research both in the industry and academia, as well as their multidisciplinary backgrounds

  • This book touches on a complete range of topics, from early research to post-marketing; health care issues impacting product development; organization and planning; marketing role in research; and the 5 special therapeutic areas

  • Includes supplementary material: sn.pub/extras

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Table of contents (12 chapters)

  1. Front Matter

    Pages i-xvi
    Download chapter PDF

  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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Keywords

About this book

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.

Reviews

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)

Editors and Affiliations

  • University of Florida, FL

    Ronald P. Evens

Bibliographic Information

  • Book Title: Drug and Biological Development

  • Book Subtitle: From Molecule to Product and Beyond

  • Editors: Ronald P. Evens

  • DOI: https://doi.org/10.1007/978-0-387-69094-0

  • Publisher: Springer New York, NY

  • eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)

  • Copyright Information: Springer-Verlag US 2007

  • eBook ISBN: 978-0-387-69094-0Published: 18 August 2007

  • Edition Number: 1

  • Number of Pages: XI, 383

  • Topics: Pharmacology/Toxicology

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