Physiologically Based Pharmacokinetic (PBPK) Modeling
Model complex drug scenarios before you ever enter the clinic—reduce risk, save time, and strengthen your strategy.
Overview of PBPK Modeling
Physiologically Based Pharmacokinetic (PBPK) modeling is a mechanistic approach used to simulate how drugs are absorbed, distributed, metabolized, and excreted (ADME) in the body. Unlike traditional pharmacokinetic models, PBPK leverages detailed anatomical and physiological parameters to represent individual organs and tissues and simulate drug movement between them.
PBPK models help researchers explore variability in drug exposure across species, age groups, disease states, and special populations—before a clinical trial even begins. PBPK modeling is increasingly used by regulatory agencies like the FDA and EMA to justify dosing strategies, reduce the need for certain studies, and strengthen submission packages with predictive evidence.
How PBPK Works
PBPK models divide the body into compartments representing real organs (liver, kidneys, lungs, etc.), linked through simulated blood flow. Each compartment is defined by both:
By incorporating both sets of variables, PBPK models can simulate complex scenarios that would be difficult—or unethical—to test directly in humans.
PBPK models are especially valuable for:
Xyzagen’s PBPK Modeling Services
At Xyzagen, we apply PBPK modeling across all stages of development to support data-driven decision-making and regulatory submissions. Our services include:
Drug-Drug Interaction (DDI) Risk Assessment
Simulate the impact of metabolic inhibitors or inducers on your compound to support labeling or waive clinical DDI studies.
Extrapolation Between Species and Populations
Use PBPK to bridge from animal data to human predictions or scale dosing strategies across populations such as: Pediatrics, Elderly, Pregnant patients, Patients with renal or hepatic impairment
Virtual Trial Simulations
Explore different trial designs and dosing regimens in silico to inform protocol development and reduce uncertainty.
Formulation & Absorption Modeling
Evaluate the impact of formulation changes or route of administration using compartmental absorption and transit models.
Regulatory Applications of PBPK
PBPK modeling is increasingly recognized by regulatory agencies, including the FDA and EMA, as a valuable tool. Xyzagen builds models aligned with regulatory expectations and helps you interpret and present results in a format that facilitates review. Key applications include:
Why Choose Xyzagen for PBPK Modeling?
We combine deep pharmacokinetics expertise with advanced modeling capabilities and seamless integration across lab and bioanalytical functions. Our approach to delivering high-quality, customized PBPK models is:
Let’s Build Your PBPK Strategy
Whether you’re predicting DDI risks, scaling pediatric dosing, or modeling organ impairment, PBPK offers insight that empowers better clinical decisions. Contact Xyzagen to explore how our PBPK modeling services can accelerate your program.
