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  • Textbook
  • © 2007

Drug and Biological Development

From Molecule to Product and Beyond

Editors:

  • 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

Buying options

eBook USD 89.00
Price excludes VAT (USA)
  • ISBN: 978-0-387-69094-0
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout

This is a preview of subscription content, access via your institution.

Table of contents (12 chapters)

  1. Front Matter

    Pages i-xvi
  2. R&D Planning and Governance

    • Ronald P. Evens, Joel Covinsky
    Pages 33-65
  3. R&D Outcomes

    • Ronald P. Evens
    Pages 66-83
  4. Discovery and Nonclinical Development

    • Stephen F. Carroll
    Pages 84-106
  5. Types of Clinical Studies

    • Lewis J. Smith
    Pages 107-122
  6. Metabolism and Pharmacokinetics

    • Jun Shi, Vijay O. Bhargava, Shashank Rohatagi
    Pages 123-147
  7. Laws and Regulations: The Discipline of Regulatory Affairs

    • Elaine S. Waller, Nancy L. Kercher
    Pages 148-177
  8. Clinical Trial Operations

    • Carl L. Roland, Paul Litka
    Pages 178-201
  9. Formulation and Manufacturing

    • Leo Pavliv, James F. Cahill
    Pages 202-221
  10. Commercial Division

    • Thomas Lytle
    Pages 222-239
  11. Medical Affairs and Professional Services

    • Ronald P. Evens
    Pages 240-274
  12. Special Considerations in Research

    • C. Michael White, Jeffrey Kluger, Jessica Song
    Pages 275-350
  13. Back Matter

    Pages 351-382

About this book

Drug and Biological Development: From Molecule to Product and Beyond offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery to product launch, continuing through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals. The text's narrative descriptions are enhanced by real-life examples, illustrations, controversies in industry, and references. Dr. Ronald Evens and his contributors are industry and research experts in a variety of disciplines.

Keywords

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

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: 978-0-387-69094-0

  • Edition Number: 1

  • Number of Pages: XI, 383

  • Topics: Pharmacology

Buying options

eBook USD 89.00
Price excludes VAT (USA)
  • ISBN: 978-0-387-69094-0
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout