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<p>Concentration-QTc (C-QTc) modeling has been widely used as the primary analysis to demonstrate assay sensitivity using moxifloxacin data in regulatory submissions for QT assessment since publication of a scientific white paper on C-QTc (Garnett et al. 2018). In this paper, several scientific issues encountered during statistical reviews of such regulatory submissions are discussed. Four common mistakes (don’ts) are described and four recommendations (dos) are made with regard to study design, statistical modeling, and interpretation of results when C-QTc is applied as primary analysis for assay sensitivity assessment. These four dos and don’ts will provide investigators with insights on how to better design and apply appropriate statistical modeling for C-QTc as the primary analysis for assay sensitivity in regulatory QT assessment.</p>

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Dos and don’ts for concentration - QTc analysis as primary analysis for assay sensitivity assessment

  • 期刊论文

  • 发表日期：

    2025年8月23日

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  • Dalong Huang

摘要

Concentration-QTc (C-QTc) modeling has been widely used as the primary analysis to demonstrate assay sensitivity using moxifloxacin data in regulatory submissions for QT assessment since publication of a scientific white paper on C-QTc (Garnett et al. 2018). In this paper, several scientific issues encountered during statistical reviews of such regulatory submissions are discussed. Four common mistakes (don’ts) are described and four recommendations (dos) are made with regard to study design, statistical modeling, and interpretation of results when C-QTc is applied as primary analysis for assay sensitivity assessment. These four dos and don’ts will provide investigators with insights on how to better design and apply appropriate statistical modeling for C-QTc as the primary analysis for assay sensitivity in regulatory QT assessment.