Some Statistical Issues Regarding to Assay Sensitivity in "Hybrid TQT" Study

• Activity Number: 359 - Contributed Poster Presentations: Biopharmacutical Section
• Type: Contributed
• Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Dalong Huang* and Janell Chen and Yi Tsong and Qianyu Dang
• Companies: FDA/CDER and FDA/CDER and CDER, FDA and FDA/CDER
• Keywords: assay sensitivity; concentration-QTc analysis; hybrid TQT study

Abstract

Since the revision of ICH E14 guidance, pharmaceutical companies have begun using the "hybrid TQT" study to meet ICH E14 regulatory requirements. The "hybrid TQT" study includes the same treatment arms (therapeutic and/or supratherapeutic dose of investigational drug, placebo, and positive control) with approximately half the sample size as the traditional TQT study. The "hybrid TQT" study uses concentration-QTc analysis for primary analysis and assay sensitivity analysis.

This poster discusses statistical issues regarding assay sensitivity in the "hybrid TQT " study using real and simulated moxifloxacin data and makes recommendations.