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Prodrugs pp 1111-1124 | Cite as

Safety Assessment of Prodrugs

  • Scott J. Grossman
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume V)

Abstract

An important aspect of drug development is the overall safety assessment process. Safety assessment considers the range of potential risks that patients may encounter, through detailed studies of preclinical species. This process guides the course of clinical development and serves as an important consideration in the ultimate benefit/risk evaluation by the sponsor and international regulatory agencies. Safety assessment is increasingly vast in scale and scope. Thus, for the purposes of this chapter, no attempt will be made to teach the process of safety assessment. The purpose of this chapter is to familiarize the reader with the various aspects of prodrugs requiring special consideration during this critical part of drug development.

Keywords

Parent Drug Risk Evaluation Safety Assessment Hydroxy Acid Good Laboratory Practice 
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.

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Copyright information

© American Association of Pharmaceutical Scientists 2007

Authors and Affiliations

  • Scott J. Grossman
    • 1
  1. 1.Bristol-Myers Squibb Co.Princeton

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