www.certara.com Open in urlscan Pro
192.124.249.52 Public Scan

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Submitted URL:
http://www.simcyp.com/
Effective URL:
https://www.certara.com/software/simcyp-pbpk/
Submission: On September 12 via api (September 12th 2022, 2:55:15 pm UTC) from US — Scanned from DE

Form analysis
6 forms found in the DOM

GET https://www.certara.com/

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POST

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GET https://www.certara.com/

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POST

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          <div style="text-align: center;"><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 18px;"><span style="font-size: 20px;">Contact&nbsp;Certara Today</span><br>Fill out this form to start a
                conversation.</span></strong></div>
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          <div class="mktoAsterix">*</div>To subscribe to updates from Certara, check here.
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            your consent, at any time.</span></div>
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Home / Software / Simcyp PBPK


PREDICT DRUG PERFORMANCE FROM VIRTUAL POPULATIONS


SIMCYP™ PBPK SIMULATOR
NEW VERSION 21

Read Success Stories


PREDICT DRUG PERFORMANCE FROM VIRTUAL POPULATIONS

The Simcyp Simulator is the pharmaceutical industry’s most sophisticated
physiologically based pharmacokinetics (PBPK) platform for determining
first-in-human dosing, optimizing clinical study design, evaluating new drug
formulations, setting the dose in untested populations, performing virtual
bioequivalence analyses, and predicting drug-drug interactions (DDIs). Simcyp is
being applied to small molecules, biologics, ADCs, generics, and new modality
drugs.

 * The Simulator includes with extensive libraries on demographics,
   developmental physiology and the ontogeny of drug elimination pathways;
 * An unmatched body of science, the Simulator includes 10 advanced mechanistic
   organs, 25 sub-populations, and 100+ compound files for use by member
   companies;
 * Links in vitro data to in vivo absorption, distribution, metabolism, and
   excretion (ADME) and pharmacokinetic / pharmacodynamic (PK/PD) outcomes to
   explore clinical scenarios and support drug development decisions;

Simcyp PBPK models describe the behavior of drugs in different body tissues,
with each tissue considered a physiological compartment. The concentration of
the drug in each compartment is determined by combining systems data, drug data,
and trial design information. The Simulator includes a unique set of genetic,
physiological and epidemiological databases that facilitate simulating virtual
populations with different demographics and ethnicities.

New Version 21 includes:

 * Hepatic and Renal Impaired Populations
 * Expansion of Genotype Library
 * Expansion of Compound Library
 * Expansion of the Human Brain Model to 5 Compartments



Most of the top 40 pharmaceutical companies are members of
the Simcyp™ Consortium.  The FDA, EMA, PMDA and other regulators use the Simcyp
Simulator.

Join the Simcyp Consortium

Analyze complex in vitro data using whole cell, tissue samples and solid dosage
samples to assess the exposure, metabolism, transport, and
dissolution/solubility of drugs

Learn about the SIVA Toolkit

Simcyp™ Animal is a PBPK modeling platform for rat, dog, mouse and monkey, used
to explain drug behavior that would be difficult to obtain via in vivo
experimentation.

Learn more about Simcyp Animal


DELIVERING ON THE PROMISE OF PBPK

In the last decade, PBPK modeling and simulation has soared in its use and
applicability—Simcyp, working with its industry, academic and regulatory
partners has led the way. The Simcyp Simulator is employed across the drug
development cycle:

 * For early pharmacokinetic determination of first-in-human dosing and to
   answer other translational questions;
 * Leveraged to support strategic decision-making, the Simulator provides
   valuable information for designing clinical trials, to reduce trial size and
   complexity and to obtain clinical trial waivers;
 * The Simulator quantitatively evaluates and predicts drug-drug interactions
   (DDIs) involving drug-metabolizing enzymes and membrane transporters, to
   evaluate PK variability as a function of ethnicity, organ impairment, and
   pharmacogenomics;
 * It predicts dosing recommendations for different populations of patients,
   including pediatrics, geriatrics, ethnicities, organ impairment.

Adopted by 11 global regulatory agencies including the US FDA, Japan’s PMDA,
UK’s MHRA and others, the Simcyp Simulator has been used to inform scores of
drugs, replacing the need for clinical trials and providing prescribing
information for approximately 300 label claims.

View 90+ novel drugs informed by Simcyp Simulator



UNIQUE CAPABILITIES—SPECIALIZED MODULES

Beyond the work within the Consortium, the Simcyp team has collaborated with
other organizations and funded its own research to develop unique modules. 
While connected to the Simulator, they require additional and optional
licensing.

Specialized modules are:

 * Simcyp Pediatric
   Simcyp® Pediatric Simulator is the industry’s most sophisticated technology
   for modeling drug performance and determining dosing in neonates, infants,
   and children.  The Simulator contains extensive libraries on demographics,
   developmental physiology, and the ontogeny of drug elimination pathways.
 * Simcyp Cardiac Safety Simulator (CSS)
   CSS is a systems biology-driven modeling and simulation-based platform for
   the assessment of the pro-arrhythmic potency of drugs, new chemical entities,
   and other xenobiotics within the targeted clinical population.  It enables
   early assessment of cardiac liability and is used for both pre-clinical and
   clinical assessment of cardiac risk.

 * Simcyp Long Acting Injectable (LAI)
   LAI drug delivery provides advantages for specific drugs and patient types,
   including reduced toxicity, reduced dosing frequency and enhanced compliance.
   Simcyp’s LAI module is used to design experiments, narrow down promising
   formulation candidates, determine animal studies or clinical trials and
   fine-tune formulation based on study details.

 * Simcyp Lactation
   Unfortunately, dosing information for pregnant and lactating women is
   generally not available on the drug label. Simcyp has been focused on this
   topic, looking at women’s health across the gestational cycle.  Simcyp
   lactation module predicts drug exposure in the mother and the milk to be
   given to the child, allowing for proper dosing of this fragile population.

Start a conversation


GAINING THE SIMCYP ADVANTAGE THROUGH CONSULTANCY

Innovative mid and smaller biopharmaceutical companies can gain the advantages
of the Simcyp PBPK Simulator outside of joining the Simcyp Consortium or
attaining licenses.  Simcyp has a team of experienced and highly credentialed
individuals that support smaller organizations on a per-project basis via
consultancy.  Generally, we begin with a feasibility assessment to determine if
the appropriate data is available to conduct the modeling & simulation with a
full project to follow.

Example projects include:

 * Drug-drug interaction simulations – perpetrator and victim
 * Absorption modelling – formulation differences, food effect, virtual
   bioequivalence
 * Dosing for special populations – pediatrics, elderly, organ impairment,
   disease conditions, ethnic differences
 * Novel routes of administration – dermal, inhalation, long-acting injectable
 * Biologics – mAbs, ADCs, cytokine mediated DDIs
 * Early PK prediction, FIH dosing

Learn about Simcyp PBPK Consulting Services



RESOURCES

Simcyp Timeline: 20 Years of Innovation
Brochure
Simcyp Publications 2021
Brochure
Certara’s Simcyp Simulator Demo
Video


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