跳转到主要内容
搜索

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
  • 以标签声明代替临床研究
  • Dosing in special populations
  • 首次人体试验 (FIH) 剂量预测
  • Absorption, food effect, and formulation assessment
  • 虚拟生物等效性(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.

Access this resource

沪ICP备2022021526号

Powered by Translations.com GlobalLink Web Software