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πŸ”§ Certara Simcyp PBPK Simulator

Certara Simcyp PBPK Simulator

The industry's most sophisticated platform for physiologically based pharmacokinetic (PBPK) modeling and simulation.

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Overview

The Certara Simcyp PBPK Simulator is a leading platform for mechanistic modeling of drug pharmacokinetics. It is widely used in the pharmaceutical industry to predict drug behavior in virtual populations, which helps in optimizing clinical trial design, assessing drug-drug interactions, and supporting regulatory submissions. The platform integrates in vitro data to predict in vivo outcomes.

✨ Key Features

  • Physiologically based pharmacokinetic (PBPK) modeling
  • Virtual populations (healthy, pediatric, geriatric, disease states)
  • Drug-drug interaction (DDI) prediction
  • First-in-human (FIH) dose prediction
  • Virtual bioequivalence assessment
  • Extensive compound and population libraries
  • Regulatory acceptance

🎯 Key Differentiators

  • Strong focus on population-based modeling and simulation
  • Extensive, well-documented compound and population libraries
  • Widespread regulatory acceptance and use in drug labels
  • Collaborative consortium model for continuous development

Unique Value: Enables the replacement, reduction, and refinement of clinical trials through validated PBPK modeling, leading to more efficient and ethical drug development.

🎯 Use Cases (4)

Clinical trial optimization Regulatory submissions Dose justification in special populations Understanding sources of pharmacokinetic variability

βœ… Best For

  • Used in over 250 drug labels for regulatory submissions to the FDA and other agencies.

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Verify these considerations match your specific requirements:

  • Not designed for de novo drug design or initial hit screening.

πŸ† Alternatives

Simulations Plus GastroPlus PK-Sim

Known for its extensive population databases and strong consortium-driven scientific development.

πŸ’» Platforms

Desktop (Windows)

βœ… Offline Mode Available

πŸ”Œ Integrations

Certara Phoenix R Other Certara products

πŸ›Ÿ Support Options

  • βœ“ Email Support
  • βœ“ Phone Support
  • βœ“ Dedicated Support (Standard tier)

πŸ”’ Compliance & Security

βœ“ GDPR βœ“ 21 CFR Part 11 compliant

πŸ’° Pricing

Contact for pricing

βœ“ 14-day free trial

Free tier: NA

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