Pharmacometrics Regulatory Strategy

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 the interactions between the human body, drug effects, and diseases. By using these models, Certara is able to help our clients identify the most informative clinical trial designs. These integrated models are being used 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 (eg, go/no-go).

Disease-Drug-Trial Modeling and Simulation

  • System Modeling and Simulation (normal human physiology and variety across patients and subpopulations)
  • Disease Modeling and Simulation (disease progression, placebo response)
  • PK/PD Modeling and Simulation (dose-exposure-safety-efficacy)
  • Trial Modeling and Simulation (patient population, enrollment dynamics, dropout, compliance, protocol deviations)

Regulatory-Compliant Population PK/PD Analysis

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

Special Populations

  • Strategies that support drug development for pediatrics and orphan drugs
  • Study designs with a minimum number of patients
  • PK/PD optimal sampling strategies
  • Trial simulation to ensure the efficacy and safety of pediatric dosing regimens

Cardiac Safety

  • QT assessment, Thorough QT/QTc (TQT) study 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 in Phase II/III
  • 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

Certara consultants help our clients achieve success by supporting regulatory communications and providing trial simulation and design support from pre-clinical studies to post-marketing.