Quantitative Pharmacology and Pharmacometrics

Right drug, right dose, right time, right patient

Quantitative pharmacology and pharmacometrics strategies underpin better decisions throughout clinical development.  Using the latest modeling techniques, we can build a more robust understanding of the factors that influence exposure and the relationships between exposure and response.  By providing more objective criteria for decision-making, our team helps you to avoid the ambiguous results that waste precious resources and put future trials at risk.   Whether you are looking for strategic input to engineer your clinical programs using learn and confirm methodology in line with FDA MIDD goals; or simply need targeted advice for specific concerns, we can help.

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qpproadmap

Build a knowledge bridge with exposure-response modeling

Cytel’s exposure response modelling techniques build a knowledge bridge between the drug and the body. This yields vital information about optimal dose strength and frequency, impact of concomitant medications, and any dose impact on safety.

Our consultants will work with you to interpret these results; giving you with the insights you need to enter your next phase of development with confidence.

 

Integrate quantitative expertise to learn and confirm

We can draw on a deep well of quantitative in-house knowledge. Depending on your study, we can seamlessly integrate traditional and innovative methods, as well as blend biostatistics and adaptive strategies with pharmacometric approaches. These approaches will equip you with the information you need to make objective decisions about your clinical development program.

 

Reduce uncertainty with rigor

Cytel has a longstanding reputation for well-designed, properly implemented analyses that produce results you can trust and which crucially satisfy the regulators. 

 

Here are some of the ways we can help you pursue your developments to their full potential:

Clinical Pharmacology & Translational Biology 
  • Quantitative Review
  • Support for Analytical Plans, including Statistical Analysis Plans and population modeling plans
  • Support for regulatory documents, including submission documents and regulatory requests
 
Enhanced Clinical Trial Design (ECTD)
 
Model-Based Meta-Analysis (MBMA)
  • Systematic Literature Review
Model-Informed Drug Development (MIDD)  
  • Advanced Analytics
  • Artificial Intelligence / Data Science / Machine Learning
  • Concentration-QTc Analysis
  • Modeling and Simulation (M&S)
  • Population PK Analysis
Pharmacometrics
  • Exposure: Response Modeling
  • Noncompartmental PK Analysis (NCA)
  • Population Pharmacokinetic Modeling (pop PK)
  • Pharmacokinetic/Pharmacodynamic (PKPD) Modeling
  • Physiologically-Based Pharmacokinetic (PBPK) Modeling
  • Quantitative Systems Pharmacology (QSP)

Resources

On-Demand Webinar: Optimizing Drug Development with Model-Informed Decision-Making

In this webinar, Tina Checchio, Associate Director of Strategic Consulting at Cytel highlights areas that are frequently supported by pharmacometric modeling and simulation, with a focus on the ways that strategic applications of pharmacometric approaches may be used to increase confidence at critical development milestones.

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Case Study: Dose-response modeling informs Phase 2 ulcerative colitis study design

simon-abrams-k_T9Zj3SE8k-unsplashCytel pharmacometricians devised a modeling approach to answer two key questions for an upcoming phase 2 trial of their ulcerative colitis compound.

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4 Questions to Explore in Model-Informed Drug Development



benjamin-child-GWe0dlVD9e0-unsplashIn this blog, we share a new Cytel infographic highlighting 4 key questions a sponsor can explore to apply these approaches within their development programs.

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