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Safety Regulations In 1997 the Committee for Proprietary Medicinal Products (CPMP) of the European Union adopted a 'Points to Consider' document which made recommendations for non-clinical and clinical approaches to assess the risk of QT prolongation and torsades de pointe for non-cardiovascular drugs. The strategies suggested have now been harmonized by the International Conference of Harmonization (ICH) in guidelines S7B and E14 for non-clinical and clinical evaluation respectively. Both of these regulatory recommendations were implemented by the European Union and FDA in 2005, while Canada adopted the recommendations in 2006. The MHLW in Japan is expected to follow suit. According to ICH S7B in vitro electrophysiological testing of compounds against hERG should be used as part of an integrated risk assessment of QT prolongation.
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