Introduction to PBPK Modelling and Simulation

Physiologically Based Pharmacokinetic (PBPK) modelling and simulation is a dynamic approach that integrates drug properties with species physiology to simulate drug concentration in plasma and tissues. This method provides a comprehensive, data-driven approach that enhances decision-making, optimizes resources, and reduces drug discovery and development risks. By describing the body as interconnected compartments representing actual tissues, PBPK models offer significant advantages in understanding how a drug behaves within the body, predicting human pharmacokinetics (PK), and optimizing drug formulations.

Pharmaron’s PBPK Capabilities and Strategic Partnerships

Pharmaron’s PBPK platform provides end-to-end value from early discovery to clinical development. The platform supports early high-throughput PBPK modelling, preclinical model verification, early human dose predictions, and formulation optimization. Pharmaron also offers strategic partnerships, leveraging software platforms like SimulationsPlus’ GastroPlus for mechanistic absorption and compartmental PK modelling. These capabilities enable Pharmaron to deliver tailored solutions for drug discovery, clinical development, and regulatory preparation, ensuring optimal formulation and bioavailability for animal studies and clinical trials.

Applications and Benefits of PBPK Modelling

PBPK modelling and simulation offer numerous applications in drug discovery and development:

• Early prediction of human PK and dose.
• Optimization of drug formulations.
• Assessment of developability potential and risk mitigation strategies.
• Supports the design and conduct of required experiments.
• Predicts drug behaviour across populations.
• Enhances regulatory support and translational PKPD studies.
• Accelerates time-to-market and maximizes use of preclinical data.
• Early DDI evaluation of drug candidates.

Why Choose Pharmaron?

• Highly experienced team with multi-decade expertise in pharma and biotech.
• Expertise in in vitro ADME, in vivo PK, metabolism, transporters, DDI, PBPK modelling, bioanalysis, PKPD.
• Delivers comprehensive candidate molecules, IND, and NDA packages.
• Combines strategic knowledge with experimental capabilities for project success.

Download the PBPK Service Overview to explore how Pharmaron’s PBPK modeling and simulation services predict drug exposure in preclinical and clinical settings. These services enable informed decision-making for efficacy, safety, and dose prediction through lead optimization, candidate nomination, and First-in-Human studies.