Updated Q&A document clarifies key issues of the ICH E14 Guidance
A revision of the ICH document titled E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs – Questions and Answers (November 2008) has been issued.
Since the ICH E14 guidance was finalized, experiences implementing the guidance in the ICH regions gave rise to requests for clarification. As a result, a question and answer (Q&A) document was created to facilitate the implementation of the E14 guidance by clarifying the key issues in 2008 and has since been updated to address additional questions.
As a member of the Cardiac Safety Research Consortium (CSRC), Altasciences participates with industry leaders on crucial matters that impact cardiovascular safety, including alternative approaches to ICH E14 for the assessment of arrhythmia liability in early drug development. We are well-positioned to support the classic thorough QT studies and/or today's early precision QT studies.