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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:
- Quantitative Review
- Support for Analytical Plans, including Statistical Analysis Plans and population modeling plans
- Support for regulatory documents, including submission documents and regulatory requests
- Systematic Literature Review
- Advanced Analytics
- Artificial Intelligence / Data Science / Machine Learning
- Concentration-QTc Analysis
- Modeling and Simulation (M&S)
- Population PK Analysis
- 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)
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.
Cytel pharmacometricians devised a modeling approach to answer two key questions for an upcoming phase 2 trial of their ulcerative colitis compound.
In this blog, we share a new Cytel infographic highlighting 4 key questions a sponsor can explore to apply these approaches within their development programs.