Safety First - Pharmaceutical Business Review

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Published 12 January 2011 | By CoreLab Partners

Cardiac safety is a relatively new field in drug development clinical research. It first emerged as a regulatory focus after the high‐profile withdrawals of drugs such as terfenadine and cisapride in the 1990s, and became synonymous with drug‐induced QT prolongation and its associated cardiac arrhythmia – torsades de pointes (TdP). Recent regulatory guidance, most notably ICH‐E14, brought cardiac safety into the forefront of regulatory medicine. Since 2000, cardiac safety became the primary reason for drug withdrawals and non‐approval of new drugs. Early detection of potential QT prolongation and TdP liability is now an essential component of the drug development paradigm.

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