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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: N/A
Therapeutic Area: Edmundo Muniz
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The Benefits of Biosimulation in Drug Development

Biosimulation has the ability to influence every phase of the drug development process, including the commercial decisions around the...
Author(s): N/A
Solution: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Publication: N/A
Therapeutic Area: N/A
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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...
Author(s): N/A
Solution: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, PK/PD Modeling & Simulation
Publication: N/A
Therapeutic Area: N/A
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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...
Author(s): N/A
Solution: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, PK/PD Modeling & Simulation, Model-based Meta-analysis
Publication: N/A
Therapeutic Area: N/A
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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...
Author(s): N/A
Solution: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, PK/PD Modeling & Simulation, Model-based Meta-analysis, Systems Pharmacology
Publication: N/A
Therapeutic Area: N/A
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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...
Author(s): N/A
Solution: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, PK/PD Modeling & Simulation, Model-based Meta-analysis, Systems Pharmacology, PBPK Modeling & Simulation
Publication: N/A
Therapeutic Area: N/A
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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,...
Author(s): N/A
Solution: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, PK/PD Modeling & Simulation, Model-based Meta-analysis, Systems Pharmacology, PBPK Modeling & Simulation, PBPK Modeling & Simulation
Publication: N/A
Therapeutic Area: N/A
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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...
Author(s): N/A
Solution: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, PK/PD Modeling & Simulation, Model-based Meta-analysis, Systems Pharmacology, PBPK Modeling & Simulation, PBPK Modeling & Simulation, Biosimulation, Regulatory & Medical Writing
Publication: N/A
Therapeutic Area: N/A
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Modeling and Simulation Supports Post-Approval Commitment in Oncology

Modeling strategy provided sponsor with rational basis for quantifying efficacy benefit of approved dose to avoid Phase IV trial,...
Author(s): N/A
Solution: Biosimulation, Drug Development & Regulatory Strategy, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, PK/PD Modeling & Simulation, Model-based Meta-analysis, Systems Pharmacology, PBPK Modeling & Simulation, PBPK Modeling & Simulation, Biosimulation, Regulatory & Medical Writing, Drug Development & Regulatory Strategy, PK/PD Modeling & Simulation
Publication: N/A
Therapeutic Area: N/A
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