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Simcyp Access

Simcyp Access is a new cloud-based offering from the leading provider of physiologically-based pharmacokinetic (PBPK) modeling and simulation. Simcyp Access is a licensing approach that provides trained individuals at smaller pharmaceutical companies (less than 500 employees) with a method for using Certara’s Simcyp Population-based Simulator in research projects.

Solution: PBPK Modeling & Simulation
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Changing the Game in Drug Development: A Selection from Certara’s Best of Blogs

A selection of short essays from our blog containing insights from our thought leaders on how modeling and simulation has impacted and is continuing to reshape our approach to drug development.

Author(s): Craig Rayner, Karen Rowland Yeo, Rik de Greef, Thomas Peyret
Solution: Biosimulation, Drug Development & Regulatory Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Central Nervous System, Oncology/Hematology, Rare/Orphan Disease
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Quantify RA Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on all biologics as well as newer synthetic DMARDs currently approved or in development for rheumatoid arthritis (RA). Information on older treatment options (MTX and other DMARDs) was included if they are used as active controls.

Solution: Clinical Trials Simulation
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Quantify Chronic Kidney Disease Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for Chronic Kidney Disease (CKD) progression
in patients with Type 2 Diabetes Mellitus (T2DM) and overt albuminuria/proteinuria, as well as patients with IGA nephropathy.

Solution: Clinical Trials Simulation
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Quantify CD Clinical Outcomes Database

The current version of the database contains information from randomized controlled trails on all current biologic and small molecule drugs that are evaluated for moderate-to-severe Crohn’s disease in patients that failed conventional treatment.

Solution: Clinical Trials Simulation
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Quantify AS Clinical Outcomes Database

The Quantify AS Clinical Outcomes Database is developed to document clinical safety and efficacy information from randomized controlled trials investigating biologics currently approved or in development for ankylosing spondylitis (AS).

Solution: Clinical Trials Simulation
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Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

Author(s): Behtash Bahador, Bernd Wendt, Chris Lovejoy, Christine Yuying Gao, Craig Rayner, Ellen Leinfuss, Karen Rowland Yeo, Lora Killian, Manoranjenni Chetty, Neil Benson, Nirpal Singh Virdee, Patrick Smith, Rik de Greef, Serge Guzy, Steve Sibley, Suzanne Minton, Tatyana Wanderer, Thomas Peyret, Venkateswari Muthukrishnan
Solution: Biosimulation, Clinical Trials Simulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Systems Pharmacology
Therapeutic Area: Central Nervous System, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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Certara Optimize: Changing the Game in Drug Development

Certara Optimize is a strategic and programmatic approach to drug development that leverages our expertise in drug development, clinical pharmacology, the use of quantitative analysis methods, and regulatory science to optimize decision-making.

Solution: Biosimulation, Drug Development & Regulatory Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing
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