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The Future of Drug Development is Virtualized and Personalized

Today, drug development is carried out in human subjects and animals. However, as computing power and the number of...

Author(s): Edmundo Muniz
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation
Publication: Clinical Researcher
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The Benefits of Modeling and Simulation in Drug Development

Modeling and simulation influences every phase of the development process, including the commercial decisions on the benefits of bringing...

Solution: PBPK Modeling & Simulation, PK/PD Modeling & Simulation
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Streamline CDISC Electronic Data Submissions: Technology Solution for CDISC PK Study Data

Through our collaborations with regulatory agencies, and partnerships with major global nonprofits, we, at Certara, continuously strive to provide...

Solution: PK/PD Modeling & Simulation
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Model-based Meta-analysis: An Innovative Methodology Comes of Age

MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions. The insights gained via...

Solution: Model-based Meta-analysis, PK/PD Modeling & Simulation
Therapeutic Area: Cardiovascular
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Status of Quantitative Systems Pharmacology Modeling in the Pharmaceutical Industry: A Consortium Survey of the What, When and How

The results of a survey, conducted by an industry-sponsored QSP consortium managed by Certara, to assess the QSP landscape...

Solution: Systems Pharmacology
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PBPK Modeling in Regulatory Review, Product Labeling and Safety Monitoring

Physiologically-based pharmacokinetic (PBPK) modeling can address various questions raised in drug development and regulatory review, and is used most...

Solution: PBPK Modeling & Simulation
Therapeutic Area: Cardiovascular, Oncology/Hematology, Rare/Orphan Disease
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Modeling the Influence of Ethnicity on Drug Disposition

A major global pharma company approached Certara scientists to develop a virtual Chinese population to assist with decision-making regarding clinical...

Solution: PBPK Modeling & Simulation
Therapeutic Area: Infectious Disease
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Integrating Regulatory Writing and Modeling and Simulation into the Drug Development Process

This approach is not just a decision-making aid to reduce cost and time, but an ethical imperative to optimize...

Solution: Model-informed Drug Development, Regulatory & Medical Writing
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Engaging the Public in the Clinical Research Process

The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few...

Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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Modeling and Simulation Supports Label Claims for New Combination Treatment for Oncology

Certara leverages its modeling and simulation technology to facilitate regulatory approval for a targeted treatment for melanoma.

Solution: PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Using PBPK to Support the Approval of Imbruvica®, a Breakthrough Cancer Drug

Leveraging the US FDA’s accelerated approval programs, Pharmacyclic generated PBPK models using the Simcyp Simulator to inform dose, dosing...

Solution: PBPK Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Taking Drug Development into the Virtual World

In her series of profiles of bioinformatics companies, Sophia Ktori looks at the work of biosimulation specialist, Certara.

Author(s): Sophia Ktori
Solution: Model-based Meta-analysis, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Systems Pharmacology
Publication: Scientific Computing World
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Learning from Failure: Leveraging Biosimulation for Pediatric Drug Development Success

The high rate of trial failures, increasing regulatory demands, and ethical imperatives all require a reexamination of the current...

Author(s): Trevor Johnson, Jean-Francois Marier, Suzanne Minton
Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Publication: Applied Clinical Trials
Therapeutic Area: Central Nervous System, Pediatrics, Rare/Orphan Disease
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Population Pharmacodynamic/Pharmacokinetic Modeling of Eculizumab and Free Complement Component Protein C5 in Pediatric and Adult Patients with Atypical Hemolytic Uremic Syndrome (aHUS)

Author(s): C. D. Lathia, N. Kassir, M. S. Mouksassi, B. Jayaraman, J. F. Marier, C. L. Bedrosian
Event: ASCPT (American Society for Clinical Pharmacology & Therapeutics) Annual Meeting
Year: 2014
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