Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers

On 27 August 2020 the ICH E14/S7B Implementation Working Group (IWG) announced the availability of the ICH E14/S7B Draft Q&As.

ICH S7B and ICH E14 describe nonclinical and clinical risk assessment strategies to inform the potential risk for proarrhythmia of a test substance and contribute to the design of clinical investigations. Emergent data over the past several years demonstrate that different experimental results can arise for the same compound as a function of the study conditions used in nonclinical assays.

The ICH E14/S7B draft Q&A document on “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential” reached Step 2b of the ICH Process on 27 August 2020 and now enters the consultation period.

On 15 and 16 October 2020, a public webinar (ICH WG Presentations and Live Q&A) will be held to provide an overview of the high-level principles and rationale behind the new interconnected Q&As to ICH E14 and S7B and to answer questions received during the webinar.

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