ICH Project ICH S7B Implementation Working Group: “Nonclinical Evaluation of QT/QTc Interval Prolongation and Potential Arrhythmogenicity,” Mini-Symposium on Participation in the Study Group on In Vivo QT Best Practice Test Methods
May 8, 2024
Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Section 3 outlines best practices for in vivo QT studies.While an overview of how to apply these best practices is provided in training materials and other resources, the development and validation of test methods are required to be conducted in accordance with the specific testing conditions of each individual facility. At the same time, there are opinions that clear criteria are needed regarding the conditions under which regulatory authorities will accept test methods and validation results.In particular, regarding the “definition of minimal detectable difference (MDD),” which is presented in Section 3.4 of the Q&A as one of the methods to ensure the new measurement sensitivity, there is no prior experience with its use in current nonclinical QT evaluations; therefore, we believe it is necessary to conduct and evaluate tests based on standardized methods.
In light of the above, with the aim of examining standard testing and evaluation methods for the application of in vivo QT test best practices, the AMED Research Group “Research Contributing to the Development of Domestic Infrastructure and Promotion of International Harmonization Regarding Evaluation Methods for Ensuring the Quality and Safety of Pharmaceuticals, Collaborative Research:Research on the Evaluation of Ventricular Repolarization Delay (QT Interval Prolongation) in Nonclinical Studies,” we are considering forming a research group to address this issue and conducting investigations and research on standardized methods for evaluating MDD, among other topics, using actual test data.
The purpose of this mini-symposium is to present the background, challenges, and research objectives behind the formation of the research group, and to solicit applications from companies and contract research organizations wishing to participate in the research group to address these challenges.
Details regarding the program and other information for this symposium are available on the PMDA website.