Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation 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.

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Status of QSP Modeling in the Pharmaceutical Industry

Steve Toon

A primary cause of failures in pharmaceutical research and development (R&D) has been attributed to lack of efficacy1, suggesting inadequate understanding in therapeutic targets’ biology and their relevance to disease progression or modulation. Quantitative systems pharmacology (QSP) has the promise of increasing the probability of success in R&D by bridging scientific gaps between disciplines to […]

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Topics: Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation

Quantitative Systems Pharmacology Brings Value to Drug Development

Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.

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How to Optimize Your Drug Label Using Biosimulation Methodology

While biosimulation has been an important element in drug development for some time, its impact over the past 18 months with regard to label optimization has been profound. Specifically, FDA’s acceptance of Physiologically-Based Pharmacokinetic (PBPK) modeling and simulation has impacted key label elements in more than a dozen cases, driving down R&D costs and timelines, […]

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How to Optimize Your Drug Label Using Biosimulation Technology

Steve Toon

As a trained pharmacist and scientist, I think a lot about patient care and how the drug development process impacts drug labels and the clinical use of medicines. Biosimulation technology encompasses methods such as physiologically based pharmacokinetic (PBPK) models. PBPK provides insight into drug mechanisms. It also helps clinicians provide the safest and most effective treatment to patients.

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Topics: Model-based Drug Development, PBPK Modeling and Simulation
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