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™ specialized modules
Simcyp の多様なモジュール
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. このシミュレータには、人口統計、発生生理学、薬物排泄経路の個体発生に関する広範なライブラリが搭載されています。
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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. cardiac liabilityの早期評価を可能にし、心臓リスクの前臨床および臨床評価の両方に使用されます。
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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のLAIモジュールは、実験計画の立案、有望な製剤候補の絞り込み、動物実験や臨床試験の決定、試験内容に基づく製剤の微調整に使用されます。
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.
バーチャルの生物学的同等性
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. また、BE統計解析の実施、仮想BE試験の検出力の評価、臨床的に適切な溶出安全域の決定も可能です。
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Simcyp生物製剤
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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Simcyp applications
全て見る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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