Navigating drug development requires a strong focus on safety, especially cardiac function. The ICH E14/S7B guidelines offer a framework for evaluating the risk of QT interval prolongation and proarrhythmic potential. By integrating nonclinical and clinical data, these guidelines help streamline the assessment process and potentially reduce the need for extensive clinical studies.
In this insightful webinar, expert Ty Speece provides a comprehensive overview of the crucial ICH E14/S7B guidelines for evaluating cardiovascular safety in drug development. Learn how to effectively integrate nonclinical and clinical data to streamline your assessment process and potentially optimize your study designs.
Key Benefits:
- Clear Guidance: Understand the harmonized approach to nonclinical cardiovascular safety evaluation.
- Potential for Efficiency: Explore opportunities to optimize study designs and potentially waive thorough QT (TQT) studies.
- Improved Predictability: Gain insights into enhancing the reliability of cardiovascular safety assessments.
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