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Safety studies

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Phase I studies can be used to look at specific safety issues in drug development. For example, based on pharmacology or toxicology results, a drug may be thought to have potential to cause QT interval prolongation on the ECG which may predispose to cardiac arrhythmias. A simple Phase I study using an escalating dose of drug with ECG recording can show whether there is any relationship between concentration of drug in the plasma and QT interval.

Clinical Pharmacology and Therapeutics

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