Explore First: How a Stepwise Approach to QTc Studies Reduces Time, Cost, and Regulatory Risk

開催日: Jul 24, 2025

開催時間 11am ET

関連ソリューション：Preclinical, Early Clinical, Late Clinical, Regulatory

関連サービス：Modeling and Simulation, Drug Development

関連ソフトウェア： Simcyp™, Quantitative Systems Pharmacology, Phoenix™

概要

A smarter, data-driven approach to QTc analysis can accelerate your development timeline while minimizing costs and regulatory risk. Traditional models often rely on a one-size-fits-all solution—an approach that can either miss opportunities for streamlined TQT studies 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 study, 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

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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 study or reassessing your current strategy, don’t miss this chance to advance safety and your drug candidate.

Key Learning Objectives:

Learn how exploratory concentration-QTc analysis can inform smarter decision-making early in development
Understand when and how to justify waivers, design focused TQT studies, 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 studies and downstream risk