Quantitative Model Informed Drug Development
Cutting-edge modeling and simulation solutions that turn complex data into actionable insight—enabling smarter, faster, and safer development of novel therapies.
What is Quantitative Model-Informed Drug Development?
Quantitative Model-Informed Drug Development (MIDD) is reshaping how therapies are developed, tested, and brought to market. By combining pharmacokinetic (PK), pharmacodynamic (PD), and exposure-response data with advanced modeling and simulation techniques, MIDD helps reduce risk, improve efficiency, and support regulatory interactions.
Xyzagen understands that these approaches are essential for dose optimization, study design, regulatory submissions, and risk reduction across all phases of development. Regulatory agencies, including the FDA and EMA, increasingly encourage the use of MIDD strategies to support smarter and faster clinical programs, and the International Council for Harmonisation (ICH) is also developing draft guidance to further standardize their application globally.
Xyzagen’s Quantitative & MIDD Capabilities
At Xyzagen, we integrate powerful computational tools with deep scientific expertise to support model-informed strategies across the drug development lifecycle. Our approach is collaborative, flexible, and focused on generating clear, actionable insights for your team.
Whether you need a population PK model for a first-in-human study or a PBPK model to simulate virtual patient populations, our quantitative solutions are built to accelerate development while minimizing uncertainty. All modeling is designed in close alignment with your compound’s characteristics, therapeutic area, and development stage.
How Xyzagen Delivers MIDD Value
Whether you’re preparing for a regulatory milestone or optimizing your next trial, our model-informed drug development services deliver actionable insights—fast. Our approach is grounded in scientific rigor and tailored to your specific program needs.
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Deep expertise in both noncompartmental and compartmental modeling
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Seamless data integration with internal wet lab, bioanalytical, and regulatory services
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Custom model development tailored to compound-specific characteristics
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Strategic insights to support regulatory discussions, trial design, and go/no-go decisions
Core Service Areas
Modeling & Simulation
By leveraging modeling and simulation we help clients enhance decision-making, optimize study designs, and can reduce the need for costly and time-consuming trials. Learn how our modeling strategies can support both nonclinical and clinical programs.
Population PK (PopPK) Modeling
Our PopPK and exposure-response models assess variability in drug exposure across diverse patient populations. These tools help define appropriate dose levels and frequency, particularly in special populations such as pediatrics or patients with renal impairment.
Physiologically Based Pharmacokinetics (PBPK) Modeling
Our PBPK models simulate ADME processes using detailed physiologic parameters and compound-specific data. These simulations provide insights into complex scenarios across populations before a clinical trial even begins.
Pharmacodynamic (PD) Modeling
With our pharmacodynamic (PD) modeling you can link drug exposure to effect to identify optimal dosing, refine endpoints, and guide trial design. We connect nonclinical and clinical data to speed decisions and reduce risk.
What Sets Us Apart?
Boutique Approach
Senior scientists lead every engagement. No middle layers—just deep expertise.
Fast Execution
We integrate data and models to accelerate go/no-go decisions and value inflection.
Integrated Services
Our modeling aligns with in-house bioanalytical, lab, and regulatory services for an end-to-end workflow from data generation to interpretation.
Decision-Focused Outputs
Every model is built for your specific program goals, disease area, and regulatory needs.
Tailored Solutions
Our models deliver more than simulations—they generate insights that drive better decisions, faster.
Partner with Xyzagen
Looking to apply model-informed strategies to your next study? Collaborate with a team that understands both the science and the strategy.
Xyzagen offers a nimble, expert-driven partnership model to support your development from discovery through approval. Contact us today to learn how Xyzagen’s Quantitative MIDD capabilities can optimize your development pathway and improve program outcomes.
