将 Simcyp PBPK Simulator 集成到药物开发程序中的主要 10 益处

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.

Most importantly, Simcyp Simulator will allow you to bring drugs to patients faster and improve ROI through smarter decision-making, improved compound selection and trial avoidance/reduction. Join the 35 Simcyp Consortium members, 130+ Biotech companies, 100+ Academic partners and >10 Global Regulatory agencies.The Simcyp Simulator provides benefits across the development cycle

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