The Standard for Population-Based Pharmacokinetic Modeling and Simulation
Used by all of the top 10 global pharmaceutical companies, together with the U.S. Food and Drug Administration (F.D.A.) and other key regulatory agencies, the Simcyp® Simulator is the industry’s most sophisticated solution for assisting in dose selection and informing product labeling. It links in vitro data to in vivo ADME (absorption, distribution, metabolism, and excretion) and pharmacokinetic/pharmacodynamic (PK/PD) outcomes to help explore potential clinical complexities prior to human studies and support decision-making in drug development.
With the Simcyp Simulator, researchers can:
- Support strategic decision making: It provides valuable information relating to clinical trial design and can help obtain clinical trial waivers.
- Save time and money: The automated prediction of in vivo outcomes accelerates the assessment of large numbers of compounds.
- Optimize drug labels: In recent years, it was used by clients to perform 66 drug-drug interaction (DDI) studies virtually.
- Gain access to leading edge R&D: It is the result of more than 12 years of collaboration with a Consortium that now includes leading pharma companies, academia, and major regulatory bodies in an ongoing development program.
- Decrease risk to patients: It helps identify individuals whose genetic and physiological characteristics place them at greatest risk of adverse drug reactions.
- Easy to use: It has an intuitive user interface. Users gain proficiency quickly through attending training workshops.
- Automated in vitro extrapolation to predict in vivo outcomes, supporting the assessment of large numbers of compounds metabolized by multiple enzymes
- Incorporates inter-subject physiological variability
- High speed, user-friendly desktop application
- Batch processing facility
- Transparent algorithms and methodology and easily understood visual outputs through a variety of graphical interfaces
- Incorporates leading edge science with continually updated databases
- Consortium members guide the development of the Simcyp Simulator and share ‘best practices.’
- Users are supported by scientific and technical teams.
Modules with the Simcyp Simulator include:
Learn more about the science of the Simcyp Simulator:
- Virtual Populations
- Drug Metabolism
- Prediction of Clearance
- Prediction of Drug-Drug Interactions
Conducting clinical trials incurs immense costs. Thus, technologies that change clinical trial practices represent a sea change in drug development. Sponsors and regulatory agencies routinely use physiologically-based pharmacokinetic (PBPK) modeling and simulation to manage clinical trials. Join the biosimulation revolution and see how the Simcyp Simulator can help your drug achieve regulatory success.