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New Drug Development

  • J. Rick Turner
Chapter

Abstract

The word drug has various connotations in everyday language. In this book, it refers specifically to traditional pharmaceuticals and biopharmaceuticals (biologicals) that safely and effectively treat or prevent biological states of clinical concern. The text discusses the development of new ethical drugs, drugs that must be prescribed by a physician. In the case of small molecule drugs, attention focuses on the development of a drug containing a novel chemical compound, i.e., a new chemical entity (NCE) or new molecular entity (NME), as its active ingredient. In the case of biologicals, attention focuses on proteins that are produced via the large-scale cultivation of microbial or mammalian cells.

Keywords

Investigational Drug Small Molecule Drug Marketing Approval Clinical Development Program Operational Execution 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Turner JR, Durham TA, 2009, Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance. Hoboken, NJ: Wiley.Google Scholar
  2. Piantadosi S, 2005, Clinical Trials: A Methodologic Perspective, 2nd Edition. Hoboken, NJ: Wiley.Google Scholar
  3. Derenzo E, Moss J, 2006, Writing Clinical Research Protocols: Ethical Considerations. San Diego: Elsevier.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  1. 1.Cardiac Safety Services QuintilesDurhamUSA

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