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Drug and Biological Development pp 5–32Cite as

Health Care and Industry Overview and Challenges

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Drug and biological product development is a global, massive, complex enterprise that entails health care systems, disease knowledge, drug knowledge, research experiences (basic and clinical research with many disciplines, technologies, and processes), personnel/professional affairs, business and marketing practices, public relations, legal and regulatory issues, and global business, cultural, and medical factors. This chapter is intended to provide some background context for product development regarding applicable general health care issues, a description of the industry and key statistics, the organization of a pharmaceutical company, and drug and biological product development challenges. Thus, a framework is provided for the following 11 chapters that will discuss all the people, processes, systems, and outcomes for drug and biological development applicable in the United States and in Europe as well.

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Author information

Authors and Affiliations

  1. University of Florida, Jacksonville, FL

    Clinical Professor Ronald P. Evens Pharm D., FCCP

Authors
  1. Clinical Professor Ronald P. Evens Pharm D., FCCP
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Editor information

Editors and Affiliations

  1. University of Florida, Jacksonville, FL

    Ronald P. Evens Pharm D., FCCP

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© 2007 Springer Science+Business Media, LLC

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Evens, R.P. (2007). Health Care and Industry Overview and Challenges. In: Evens, R.P. (eds) Drug and Biological Development. Springer, Boston, MA. https://doi.org/10.1007/978-0-387-69094-0_1

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