Pharmacometrics

Predictive Disease-Drug-Trial Modeling and Simulation

For more than 15 years, our scientists have provided a unique combination of insight and innovation building quantitative models of diseases, drugs (PK/PD) and clinical trials. Once developed, the value of these integrated models comes in using them to design, test and explore various untested clinical scenarios through computer-based simulation. Our core offerings and expertise support dose selection, trial design, labeling and strategic program decisions (e.g., go/no-go).

Disease-Drug-Trial Modeling and Simulation

• Disease Modeling and Simulation (disease progression, placebo response)
• PK/PD Modeling and Simulation (dose-exposure-safety-efficacy)
• Trial Modeling and Simulation (patient population, dropout, compliance)

Regulatory-Compliant Population PK/PD Analysis

• PK/PD analysis, modeling and reporting of sparse/rich data

Special Populations: Pediatrics, Rare Diseases

• Study design, PK/PD sampling strategies, trial simulation

Cardiac Safety: QT assessment, TQT design and analysis

• Pooled analysis of early phase I/II data to influence timing and design of TQT
• C-QT modeling of TQT data

Product Profile Assessment: Clinical Utility Index (CUI®) modeling

• Quantify tradeoffs for competitive positioning, trial design, new formulations

Benefits of Pharmacometric Analysis

The benefits of quantitative drug-disease-trial modeling and simulation have been well demonstrated by FDA and industry sponsors. Contact us today to see how we can help you achieve tangible benefits for your development programs, such as:

• Getting the dose right
• Designing fewer, smaller, more efficient clinical trials
• Improving interactions with regulatory authorities
• Developing therapeutics with better benefit/risk profiles
• Attracting investor funding or securing a development partner