[November 19, 2014] |
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Certara Updates Its Simcyp Simulator Used to Predict Drug Behavior in Virtual Patient Populations
PRINCETON, N.J. --(Business Wire)--
Certara®, the leading global technology-enabled drug
development and drug safety consultancy, today announced that it has
released version 14 of its Simcyp™ Population-based Simulator, which
enables biopharmaceutical researchers to predict drug-drug interactions
and pharmacokinetic-pharmacodynamic (PK-PD) outcomes in virtual human
and animal populations.
"Simcyp Simulator is the industry's most sophisticated solution for
predicting drug-drug interactions, assisting in dose selection, and
informing clinical decisions related to product labeling," said Certara
CEO Edmundo Muniz, M.D., Ph.D. "It is used by all of the top 10
pharmaceutical companies, together with the U.S. Food and Drug
Administration (FDA) and other key regulatory agencies."
The Simcyp Simulator can be used to select ideal dosing regimens;
determine drug-drug interactions; and predict PK changes in special
populations, such as neonates, pregnant women or patients with renal
impairment who receive multiple drugs, in order to inform study design
and guide appropriate labeling language.
Simcyp whole body simulation methodology can predict the
pharmacokinetics of drug compounds and proteins based on in vitro data.
The simulator includes a unique set of genetic, physiological and
epidemiological databases that facilitate the simulation of virtual
populations from around the globe.
V14 platform enhancements include the following:
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Oral absorption models - The Simcyp Simulator's ADAM (Advanced
Dissolution Adsorption Metabolism) module now contains extended
features for handling fed versus fasted oral absorption models, which
take account of some of the more complex food effects such as changes
in viscosity. In addition, its Mechanistic Permeability (Mech Perf)
human model can estimate dru permeability in different regions of the
gastrointestinal (GI) tract, including the colon.
Physiologically-based (PB) PK mechanistic models are playing an
increasingly important role in regulatory submissions to the FDA.
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Improved gut wall modeling - A Nested-Enzyme-Within-Enterocyte
(NEWE) model has been added to the simulator which takes into account
the enterocyte turnover in the gut wall and the resulting changes in
the level of intestinal drug metabolizing enzymes. Clients can now
estimate a value for the proportion of unbound drug in the gut wall
based on the physiological chemistry and blood-binding capabilities of
the drug and the tissue composition of the gut wall. This unique
mechanistic model allows the Simcyp Simulator to more closely mimic
the actual interactions of drugs with gut wall enzymes during the
absorption process.
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Updated compound libraries - The V14 platform contains new
compound files for Pravastatin, Lorazepam, Probenecid and
Cyclosporine. Moreover, Rifampicin can be administered as a single
dose to assess OATP-mediated inhibition. Updates were also applied to
the multiple-dose Rifampicin, Metoprolol and Digoxin files. In
addition to providing compound files, Certara also creates defined
patient populations to expedite virtual clinical trials. For example,
the Simcyp Simulator has virtual populations based on ethnicity such
as Japanese or Chinese, and specific physiological conditions,
including pregnant women, patients with various severity of cirrhosis,
and those with different levels of renal impairment.
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Matching real clinical trials - Clients increasingly want their
in-silico and virtual trials to match what they will do in the real
clinical trials more closely. They want to mirror the complex dose
scheduling and combinations in the form of administration. If the
initial dose will be given as an injection and then followed by
tablets, they want the same to happen in the virtual trial. In
addition to providing that capability, the simulator now also gives
clients the option of injecting drugs into specific organs and
following the kinetics using the PBPK model.
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Monitoring multiple metabolites - Clients can now monitor two
drug metabolites at the same time without having to repeat the
simulation. As drug metabolites can play significant roles in some
aspects of drug safety and pharmacological response, this is a very
practical addition to the platform.
Simcyp's clients form a Consortium which helps to guide scientific
development at the company, ensuring that its products continue to meet,
and exceed, industry needs.
Simcyp Simulator v14 is now available to all Consortium members and
academic associates with current not-for-profit license agreements.
About Certara
Certara is the leading global technology-enabled drug development and
drug safety consultancy. Its customers include hundreds of
biopharmaceutical companies around the globe, together with several
regulatory agencies. Certara's solutions, which span the discovery,
preclinical and clinical stages of drug development, enable data-driven
decisions, leading to more precisely designed trials with a reduced risk
of failure and improved subject safety. For more information, visit www.certara.com.
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