ICH Project ICH S7B Implementation Working Group: "Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects", Mini-Symposium on In Vivo QT Best Practices Study Methodology Study Group Participation
May 08, 2024
ICH S7B Q&A Section 3 on Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects provides best practices for in vivo QT studies. Although the best practices are outlined in the training materials, the development and validation of test methods should be tailored to the conditions of each individual study site. On the other hand, there is a need for clear criteria for acceptance of test method and validation results by regulatory authorities. In particular, the definition of minimum detectable sensitivity (MDD), which is presented as one of the new methods to ensure measurement sensitivity in section 3.4 of the Q&A, has not been used in the current nonclinical QT evaluations, and we believe that it is necessary to conduct/evaluate tests based on standardized methods.
In light of the above, the AMED research group "Research contributing to the development of domestic infrastructure and promotion of international harmonization concerning evaluation methods to ensure the quality and safety of pharmaceutical products," is conducting a study on the application of in vivo QT testing best practices to investigate standard testing/evaluation methods. The research group is considering forming a research group to study the subject and conducting research and surveys on standardized methods for the evaluation of MDD using actual study data.
The purpose of this mini-symposium is to present the background of the formation of the research group, the issues and objectives of the research, and to publicly invite companies and contract research organizations to participate in the research group for the purpose of solving the issues.
The details of this symposium, including the program, can be found on the PMDA website.
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