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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: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation
Publication: Clinical Researcher
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The Benefits of Modeling and Simulation in Drug Development

Modeling and simulation (M&S) has the ability to influence every phase of the drug development process, including the commercial decisions...

Solution: PBPK Modeling & Simulation, PK/PD Modeling & Simulation
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Streamline CDISC Electronic Data Submissions: Phoenix® Workflow Templates and Plugin Services

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
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

A primary cause of failures in pharmaceutical research and development (R&D) was attributed to lack of efficacy (Hay et...

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

Physiologically-based pharmacokinetic (PBPK) modeling and simulation in virtual populations can uncover changes in drug disposition due to ethnic differences,...

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

As the adoption of biosimulation for drug development expands, so too does the need to integrate it into the...

Solution: Biosimulation, 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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Phoenix Allometric Scaling Tool Accelerates Predicting First-In-Man Dosing

Global, Tier 1 pharmaceutical company engages Phoenix Technology Services to develop a new solution that streamlines designing early clinical...

Solution: PK/PD Modeling & Simulation
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Biosimulation 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. A hallmark...

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

Pharmacyclic’s (now AbbVie) Imbruvica® (ibrutinib) is an anticancer drug targeting B-cell malignancies. It blocks a specific protein called Bruton’s...

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: Biosimulation, Model-based Meta-analysis, 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: Biosimulation, Drug Development & Regulatory Strategy, 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
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