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Simcyp specialized modules

Simcyp expansions

Further to the work with the Simcyp Consortium, the Certara Simcyp team collaborates with other organizations and funds research to develop unique modules. While connected to the Simcyp PBPK Simulator, these modules require additional licensing.

Simcyp Animal

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.

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Simcyp Pediatric

Simcyp Pediatric 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.

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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.

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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

Dosing information for pregnant and lactating women is generally not available on the drug label. Simcyp is focused on this topic, looking at women’s health across the gestational cycle. The 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.

Virtual Bioequivalence

The Virtual Bioequivalence (VBE) module facilitates running a range of common BE studies incorporating within and between subjects variability and batch to batch formulation changes. It also allows conducting BE statistical analysis, assess power of virtual BE studies and determine clinically relevant dissolution safe space.

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Simcyp Biologics

The Simcyp PBPK Simulator has been expanded, enhanced, tested and applied to biologics drugs. Simcyp Biologics enables scientists to model many different biologics modalities, including monoclonal antibodies, protein conjugates, Fc-fusion proteins, bispecifics, and other proteins and peptides.

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See our Simcyp modules in action

Maximize your drug development journey with our specialized modules for the Simcyp PBPK Simulator. From predicting pediatric dosing to evaluating cardiac safety and bioavailability, Certara Simcyp offers tailored PBPK modeling solutions to meet your unique challenges. Connect with our experts to integrate advanced simulations into your pipeline and drive smarter, faster decision-making.

Address diverse populations with precise PBPK modeling.
Enhance decision-making across preclinical and clinical phases.
Confidently navigate complex regulatory landscapes.

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