Unlocking Efficiency in Drug Development with Simcyp PBPK Modeling
Complex drug-drug interactions (DDIs) are a significant roadblock in drug development. While crucial for safety, traditional methods like extensive clinical trials can be time-consuming, cost millions of dollars, and delay the delivery of potentially life-saving treatments to patients in need.
This white paper introduces Simcyp PBPK (Physiologically based pharmacokinetic) modeling as a vital tool for accurate DDI prediction and management, showcasing its role in expediting drug approval processes. It presents detailed case studies to illustrate Simcyp’s effectiveness in reducing development timelines and costs.
Submit the form to download your exclusive copy of the whitepaper and discover the power of PBPK for safer, faster drug development.
Unlock powerful benefits
- DDI prediction with precision: simulate drug interactions to forecast effects and guide labeling.
- Cut trial costs: use pre-trial insights to design efficient studies.
- Streamline approvals: utilize accurate PBPK models supported by data to secure waivers from regulatory agencies.
Proven impact
- Securing numerous DDI label claims, simplifying drug labeling, and patient safety.
- For one Certara client, we replaced over 10 clinical pharmacology DDI studies, saving significant time and resources.
- Successfully applied to complex drugs and special populations.
Favorable regulatory climate
Regulatory agencies worldwide, including the US FDA and ICH, increasingly support PBPK modeling for DDI assessment, underscoring its growing importance in drug development. Given the increasing acceptance of PBPK modeling, the time to explore its potential is now.
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