探索先行：分阶段 QTc 研究策略如何减少时间、成本及监管风险

日期 Jul 24, 2025

时间 11am ET

解决方案：Preclinical, Early Clinical, Late Clinical, Regulatory

Services: Modeling and Simulation, Drug Development

概述

A smarter, data-driven approach to QTc analysis can streamline your development timeline while minimizing costs and regulatory risk. Traditional strategies often rely on a one-size-fits-all solution—an approach that can either miss opportunities for simplified C-QTc analysis or underestimate the need for more robust analysis.

On the contrary, a stepwise strategy that begins with an exploratory concentration-QTc analysis can help chart a more efficient and cost-effective course. By pairing early insights into your data with program goals, you can determine whether to pursue a waiver, run a focused TQT analysis, or build a complex model only when truly necessary.

In this webinar, Certara experts will break down this approach and provide insight into how evolving regulatory expectations are shaping QTc evaluation

Patrick F. Smith, PharmD – SVP, Translational Science
Adekemi Taylor, PhD – VP, Regional Lead USA, Division 1, Quantitative Science Services
Kara Schmelzer, PhD – Sr. Director, Consulting

点击报名

You’ll gain a clear understanding of how exploratory analysis supports stronger decision-making, smoother regulatory submissions, and reduced downstream risk.

Whether you’re planning your first QTc analysis or reassessing your current strategy, don’t miss this chance to advance safety and your drug candidate.

Key Learning Objectives:

Understand the value of incorporating early ECG collection to facilitate exploratory C-QTc into development timelines which allows key cardiac safety decisions
Understand when and how to justify waivers, design focused TQT analysis, or build complex models
Gain insights into evolving regulatory expectations and how to align your QTc strategy accordingly
Discover how a tailored approach reduces unnecessary analysis and downstream risk