Emi Matsumoto from Translational Research Business Unit to present a poster at Safety Pharmacology Society 2026 Annual Meeting

2026.08.27

Emi Matsumoto from Translational Research Business Unit  will have a poster presentation at Safety Pharmacology Society 2026 Annual Meeting,  to be held at Centre Mont-Royal, Montreal, Canada.
If you plan to attend the conference, we encourage you to join the session and hear the presentation.

Conference Name: Safety Pharmacology Society 2026 Annual Meeting

Date & Time: September 22 (15:00-16:00, EDT), 23 (11:15-12:15, EDT), 2026

Location: Centre Mont-Royal, Montreal, Canada

Title: Demonstration of Clinically Relevant Detection Sensitivity with ICH E14/S7B Q&A: Ascending Dose Cardiovascular Telemetry Study in Dogs

Poster No: 29

Presentation Summary
ICH E14/S7B guideline Q&As require that the in vivo QT assay demonstrate a sensitivity comparable to Thorough QT (TQT) studies for detecting QTc prolongation when conducting a nonclinical integrated risk assessment for TQT waiver applications. In addition to the crossover design widely used in nonclinical studies, we evaluated two alternative designs in dog telemetry studies: a dose-escalation design and a design incorporating concurrent serial blood sampling, using moxifloxacin as a positive control. The resulting data were analyzed with our proprietary analytical approach. The results confirmed the high sensitivity and responsiveness required by the ICH E14/S7B guidelines and demonstrated clinically relevant detection performance.

Axcelead’s Soulution
Axcelead delivers high-sensitivity telemetry studies powered by proprietary expertise and proven know-how. In addition, we provide comprehensive cardiovascular safety assessment services covering all stages, from early discovery screening to integrated risk assessment in clinical development. By addressing the specific characteristics of each compound and the requirements of each development stage, we develop tailored cardiovascular safety assessment strategies that support informed and efficient decision-making throughout drug development. For any inquiries regarding cardiovascular safety assessment, please feel free to contact Axcelead. Our experienced team is ready to support your drug development programs.