Safety Assessment of Prodrugs
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.
KeywordsParent Drug Risk Evaluation Safety Assessment Hydroxy Acid Good Laboratory Practice
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