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The Simcyp Simulator
The Simcyp Population-based Simulator streamlines drug development through the modelling and simulation of pharmacokinetics (PK) and pharmacodynamics (PD) in virtual populations. The Simulator is the pharmaceutical industry's most sophisticated platform for the prediction of drug-drug interactions and pharmacokinetic outcomes in clinical populations.
It contains numerous databases containing human physiological, genetic and epidemiological information. By integrating this information with your in vitro or clinical data, the Simulator allows you to predict PK/PD behaviour in ‘real-world’ populations. This automated prediction of in vivo outcomes accelerates the assessment of large numbers of compounds, saving time and cost.
The Simcyp Population-based Simulator provides valuable information for key management decisions relating to clinical trial design, clinical trial avoidance, and drug-drug interaction (DDI) information for the Summary of Product Characteristics (SPCs) and Prescribing Information sheets.
The Simcyp Simulator can also identify key pre-clinical data requirements, which can prove extremely valuable for redefining and optimising early drug development processes and procedures.
Simcyp Population-based Simulator, Version 12 (Release 1)
Extensive research and development has been performed in 2012 and several changes have been made to expand the capability of the Simulator. R&D for Version 12 Release 1 has focused on:
- PBPK models for biologics/therapeutic proteins - it is now possible to simulate the pharmacokinetics and pharmacodynamics of therapeutic proteins using two different Simcyp models. Compound files for therapeutic proteins have also been incorporated into the Simulator.
- Mechanistic kidney models with competitive inhibition of drug transporters - a permeability-limited mechanistic kidney model (known as Mech-KiM) enables users to simulate passive permeability within the nephron, active secretion and re-absorption between the blood and the urine as well as renal metabolism and excretion. This development, and its extension to include transporter-mediated competitive drug-drug interactions using multiple inhibitors, is now a unique feature of the Simulator that makes it possible to address PK/PD/TK issues in renal disease and nephrotoxicity.
- Scalars for transporters - research has been commissioned to obtain some of the required transporters abundance values and their variability.
- Expansion of compound files - the extensive compound databases within the Simulator have been expanded, according to the priorities of Consortium members.
- Distribution – Version 12 incorporates the second part of a two year project to expand and enhance the distribution models in the Simulator. Research aspects of this project are ongoing.
In addition to the 2010 Consortium wish list, the Simcyp team has also made other modifications to enhance the Simulator. These include:
- Incorporation of time-varying anatomical and physiological parameters in the Simcyp Paediatric during the course of PK study (real time).
- Further enhancements to the Simcyp Animal models: rat, dog and mouse
- Incorporation of PD-link models for widening the applications of PKPD and trial simulation
- Expansion of the automated sensitivity analysis (ASA) tools
- A prediction tool which allows allometric scaling of renal clearance from animal PK data.
If you have any questions about Version 12 please do get in touch using the contact us form on the website.
Key features of the Simcyp Simulator:
- Transparent methods
- Automated in vitro extrapolation to predict in vivo outcomes, supporting the assessment of large numbers of compounds metabolised by multiple enzymes
- Facilitates drug development by optimising the nomination of candidate drugs and the selection and design of in vivo studies, saving time and money
- Incorporates inter-subject physiological variability
- Allows prediction of drug disposition in real-world populations
- High speed, user friendly desk-top application
- Rapid identification of the mix of characteristics of individuals at greatest risk
- Batch processing facility
- Automates multiple simulations so a large number can be run in succession without further user input. This has proved particularly useful for sensitivity analysis.
- Transparent algorithms and methodology and easily understood visual outputs through a variety of graphics interfaces
- User-friendly and informative
- Incorporates leading-edge science with continually updated databases
- Your outputs are up-to-date, based on the latest scientific data
- Consortium members guide the development of the Simulator and share 'best practice'
- Simulator meets the current and future needs of the global pharmaceutical industry
- Supported by scientific and technical teams
- Help and advice at the end of the telephone