At Biotrial, our Pop-PK & PK/PD Modeling services form the cornerstone of a model-informed drug development (MIDD) strategy. Leveraging advanced pharmacometric modeling, we help you increase understanding of your drug’s PK profile, design more efficient clinical trials, optimize dosing regimens, and de-risk your drug development program—across Phases I/III to post market.
Modeling and simulation in clinical research uses mathematical models to predict how a drug behaves in the body (PK) and how it affects the body (PD). These predictions are based on preclinical and clinical data, enabling sponsors to simulate various “what-if” scenarios without additional trials.
Understand interindividual variability in drug exposure among patient subgroups and simulate concentration-time profiles across different populations (e.g. healthy, elderly, pediatric, patients, impaired).
Link drug exposure to therapeutic and adverse effects, allowing for early identification of optimal dosing regimen.
Reduce the number of unnecessary trials by predicting drug performance before human testing
Make data-driven go/no-go decisions at every stage of development
Regulatory agencies including the FDA and EMA actively encourage model-informed approaches for dose justification and trial design.
Eliminate redundant studies and optimize resource allocation using simulation-informed strategies
Biotrial’s modeling and simulation services are seamlessly integrated with our clinical pharmacology, biostatistics, and data science teams. Whether you need a standalone PK/PD model or full-service M&S support from FIH to late-phase development, we adapt our strategy to meet your needs.
