Certara Experts Highlight Quantitative Systems Pharmacology’s Role in First-in-human Clinical Trials

PRINCETON, NJ – July 26, 2018 – Certara announced today that Clinical Pharmacology & Therapeutics has published its “Letter to the Editor” describing the important role that quantitative systems pharmacology can play in defining dosing criteria for first-in-human clinical trials, together with the European Medicines Agency’s response.

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Certara’s Best of the Blog 2017

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.

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FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Ellen Leinfuss

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

Tom Snowden

Modeling and simulation has become an indispensable part of drug development. Historically, the type of modeling employed changes as a drug moves through the stages of drug development—from discovery to pre-clinical testing to clinical trials. At the early stages of drug discovery, we may use systems biology models to identify drug targets and possible compounds, […]

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Topics: Systems Pharmacology

Taming Complex Quantitative Systems Pharmacology Models with Model Reduction

Tom Snowden

Quantitative systems pharmacology (QSP) combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. This emerging discipline integrates quantitative drug data with knowledge of its mechanism of action. QSP models predict how drugs modify cellular networks in space and time and how they impact and […]

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Topics: Systems Pharmacology

Quantitative Systems Toxicology—Taking the Cue from Aristotle

Maria Saluta

“The whole is greater than the sum of its parts” -Aristotle This quote from the great 4th century BCE Greek philosopher and scientist has become the mantra for many endeavors, sectors, organizations, and disciplines. From biology, chemistry, and physics to agriculture, engineering, and business, it is the foundation for synergy. What is the connection between […]

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Topics: Systems Pharmacology

Using Model Reduction to Bridge the QSP-Pharmacometrics Divide

Tom Snowden

Quantitative systems pharmacology (QSP) models are generally too large to be validated or fit in a traditional sense and they can become intractable to standard methods of analysis or even to the modeler’s own intuition. Model reduction can alleviate these issues of complexity by eliminating portions of a system that have minimal effect upon the […]

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Topics: Systems Pharmacology

Mechanistic Modeling of Genome Scale Molecular Interaction Networks

Andrzej Kierzek

Upon the completion of the Human Genome Project, the lead investigator, Dr. Francis Collins remarked: Science is a voyage of exploration into the unknown. We are here today to celebrate a milestone along a truly unprecedented voyage, this one into ourselves. Alexander Pope wrote, “Know then thyself. Presume not God to scan. The proper study […]

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Topics: PBPK Modeling & Simulation, Systems Pharmacology

How Model-informed Drug Development Will Increase R&D Productivity

Suzanne Minton

Will 2017 finally be the year that we overcome the blight of late-stage attrition of promising drug candidates? In a recent commentary, “Improving the Tools of Clinical Pharmacology: Goals for 2017 and Beyond,” in Clinical Pharmacology & Therapeutics, Issam Zineh and colleagues describe several areas where clinical pharmacology approaches can help reduce late-stage attrition and […]

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Topics: Clinical Pharmacology Strategy, Systems Pharmacology

Certara Launches First Global Quantitative Systems Pharmacology Consortium

PRINCETON, NJ – Jan. 25, 2017 – Certara today announced that it is launching a Quantitative Systems Pharmacology (QSP) Immunogenicity Consortium. Modeled after Certara’s highly successful Simcyp Consortium, the QSP Immunogenicity Consortium brings together leading biopharmaceutical companies in a pre-competitive environment to cooperatively develop an Immunogenicity Simulator.

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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.

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