Researcher Matsumoto from DMPK & Safety Business Unit to Present a Poster at the 17th Annual Meeting of Japanese Safety Pharmacology Society

2026.02.17

Researcher Matsumoto from the DMPK & Safety Business Unit, will deliver a poster presentation at The 17th Annual Meeting of Japanese Safety Pharmacology Society, to be held in Omiya, Saitama in Japan.
If you plan to attend the conference, we encourage you to join the session and hear the presentation.

Conference Name: The 17th Annual Meeting of Japanese Safety Pharmacology Society

Date & Time: February 27, 2026, 13:40-14:40 (JST)

Location: Sonic City, Omiya, Saitama, Japan

Title: Implementation of nonclinical C-QTc analysis: Demonstration of clinically relevant detection sensitivity with ICH E14/S7B Q&A

Poster number: P-06

Presentation Summary
ICH E14/S7B guideline Q&As require that the in vivo QT assay demonstrate a sensitivity comparable to TQT studies for detecting QTc prolongation when conducting a nonclinical integrated risk assessment for TQT waiver applications. However, verifying the sensitivity has been challenging in Japan due to the absence of standardized statistical methods for evaluating in vivo data. We conducted telemetry studies in dogs and monkeys using moxifloxacin as a positive control and analyzed the data with our proprietary approach. The results demonstrated that our test system possesses the high detection sensitivity and susceptibility required by the guidelines.

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