Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
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Applications of Genetically Modified Tools to Safety Assessment in Drug Development

  • Kay, Hee-Yeon (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Wu, Hong-Min (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University) ;
  • Lee, Seo-In (Daewon Foreign Language High School, WATCH21 Project Team) ;
  • Kim, Sang-Geon (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
  • Published : 2010.03.04
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Abstract

The process of new drug development consists of several stages; after identifying potential candidate compounds, preclinical studies using animal models link the laboratory and human clinical trials. Among many steps in preclinical studies, toxicology and safety assessments contribute to identify potential adverse events and provide rationale for setting the initial doses in clinical trials. Gene modulation is one of the important tools of modern biology, and is commonly employed to examine the function of genes of interest. Advances in new drug development have been achieved by exploding information on target selection and validation using genetically modified animal models as well as those of cells. In this review, a recent trend of genetically modified methods is discussed with reference to safety assessments, and the exemplary applications of gene-modulating tools to the tests in new drug development were summarized.

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References

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