Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program

Accelerate

1. The Simcyp PBPK Simulator enables you to accelerate your clinical development by avoiding and/or replacing clinical trials with PBPK modeling.
2. Quickly perform early PK first-in-human dose assessments to triage potential compounds with best chance of success.
3. Test alternative formulations in silico with the Simcyp Simulator.

Advise

• Advise clinical trial design to reduce the study size by refining patient cohorts via PBPK.
• Strengthen your NDA/BLA or regulatory filing package by answering ‘what if’ questions.
• Use Simcyp Simulator to make key drug development decisions from pre-IND to post-marketing.
• Bridge your data to untested populations, such as pediatrics and organ-impaired patients.

Accredited & Accepted

• Leverage hundreds of peer-reviewed papers and unique application case stories authored by Simcyp staff, industry partners, academic users, and regulators.
• Trusted and used by >10 global regulatory agencies, including the US FDA, for drug label review and approvals.
• The Simcyp Simulator is proven for attaining biowaivers and demonstrating virtual bioequivalence (VBE) in complex generics.

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