In Vitro Cardiac Safety Evaluation

The FDA and the ICH S7B provide guidelines for assessing cardiac safety. In Vitro Assays are the key strategies in cardiac safety evaluation. These assays involve the use of cell lines or isolated hearts to assess the direct effects of drugs on cardiac ion channels, particularly the hERG channel, which is associated with the QT interval prolongation.

The Comprehensive In Vitro Proarrhythmia Assay (CIPA) is an example of a modernized screening paradigm that assesses multiple ion channels and cardiomyocyte function. Manual patch clamp is the gold standard for ion channel detection methods.

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