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How to Leverage PBPK Modeling and Simulation in Drug Research and Development

Reduce clinical burden, streamline trials, and refine patient selection

Physiologically-based pharmacokinetic (PBPK) modeling is a mechanistic, model-informed approach that is widely used to support critical research and development decisions and regulatory submissions. From early discovery to late-stage development, PBPK modeling and simulation in drug development enables you to simulate outcomes, reduce uncertainty, and accelerate timelines. In this guide, explore key PBPK modeling applications that provide competitive advantage:

  • Drug-drug interaction (DDI) assessment
  • 臨床試験の代替としての適応表示の根拠付け
  • Dosing in special populations
  • ファーストインヒューマン(FIH:ヒト初回投与)投与量予測
  • Absorption, food effect, and formulation assessment
  • Virtual Bioequivalence(VBE)

Access regulatory and industry insights

What you’ll learn:

  • How to utilize PBPK modeling and simulation in drug research and development, and regulatory submissions
  • Which companies are leading the use of PBPK modeling in lieu of clinical studies
  • The types of projects delivered by Certara’s Simcyp PBPK consultancy team
  • 7 real-world case studies showing how PBPK modeling can be applied across key application areas

Apply PBPK Across the Entire Development Lifecycle

PBPK modeling supports decision-making from discovery through late-stage development.

An end-to-end PBPK strategy enables:

  • Model reuse across programs
  • Faster development timelines
  • Stronger translation to clinical and regulatory outcomes

Accelerate Development. Reduce Risk. Strengthen Submissions.

Download the guide to learn how to fully leverage PBPK modeling and simulation in drug development.

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