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Drivers
  • Drug development teams need a more robust and predictive screen than the hERG assay currently provides in order to better assess the cardiotoxic potential of new molecular candidates and thus reduce the “costs” of both false-positive and false-negative assessments.
  • Drug safety managers need and desire a more reliable system to evaluate, or rank, the relative cardiotoxic potential of new compounds that does not require the time and expense of traditional in vivo safety studies. 
  • Current methods for predictive toxicology have not performed well and are not highly regarded in the safety assessment community.
  • Effects on other ion channels are known to play a role in the genesis of serious cardio toxicities and the FDA has recently begun to emphasize the need to look at a broader spectrum of ion channel activity in addition to the potassium channel measured in the hERG assay.

 

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