Key result
Updated FDA ICH E14/S7B guidelines outline integrating preclinical and clinical data to streamline QT risk prediction.
Why the study?
The initial paradigm in the 2005 ICH E14 and S7B documents has undergone evolutionary changes to streamline drug development and improve regulatory decision-making, prompting a review of the August 2020 FDA update.
Answers are grounded in this paper and cite their sources.
This review summarizes updated FDA guidance on integrating preclinical and clinical data into QT risk prediction models for drug development.
For nearly 2 decades, regulators have adopted a harmonized approach to drug development, which has succeeded in bringing new pharmaceuticals to market without significant cardiac liability. Ushered in by technological advancements and better understanding of cellular electrophysiology, the initial paradigm detailed in the 2005 International Conference for Harmonization E14 and S7B documents has undergone evolutionary changes designed to streamline drug development and improve regulatory decision-making and product labeling. The intent of this review is to summarize the new US Food and Drug Administration (FDA) Question and Answer update from August 2020 and key messaging from a subsequent FDA webinar describing best practices for preclinical and clinical data integration into a QT risk prediction model.
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Robert M. Lester (2021) conducted a review in Drug development cardiac safety. Preclinical and clinical data integration was evaluated. The August 2020 FDA update to ICH E14/S7B guidelines outlines best practices for integrating preclinical and clinical data into a QT risk prediction model to streamline drug development.
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