ICH S7B - Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization

What it says

S7B describes a nonclinical testing strategy for assessing whether a drug can delay ventricular repolarization, which is associated with QT interval prolongation and arrhythmia risk. It recommends in vitro studies on ion channel currents and an in vivo study on QT interval, along with chemical and pharmacological class considerations, and complements the clinical guideline ICH E14.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The nonclinical results help plan the clinical QT assessment.
• The studies are core safety pharmacology studies and are generally done before first-in-human.
• Findings can be integrated with clinical data in an overall risk assessment.

What inspectors look for

• Whether the studies were performed to the recommended design.
• Whether the studies followed GLP where applicable.
• Whether the results were considered in the clinical plan.

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