Quantitative Systems Toxicology and Safety (QSTS)

Quantitative Systems Toxicology and Safety

A Pathway-based Approach to More Efficient Chemical Risk Assessment A major challenge in developing efficacious and safe drugs is the ability to understand and effectively predict adverse effects of xenobiotic substances on extremely complex biological systems early in the drug discovery process. An alarming fact is that thirty percent of adverse drug reactions (ADRs) cannot […]

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Clinical Pharmacology Gap Analysis

Increase your Odds of Regulatory Success with a Quantitative and Regulatory Science-based Strategy As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in performing a strategic assessment is a gap analysis and […]

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Quantitative Solutions

QuantitativeSolutions.net has moved to Certara.com Certara has acquired Quantitative Solutions, a global pharmacometrics consulting company headquartered in Menlo Park, California. This merger further strengthens Certara’s position in the burgeoning modeling and simulation/pharmacometric services field, broadening its modeling capabilities, deepening its therapeutic areas of expertise and adding new value-added services and clinical outcomes databases. The resulting organization is called Certara Strategic […]

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Clinical Outcomes Databases for Specific Therapeutic Areas

About our Clinical Trial Outcomes Databases Our Clinical Trial Outcomes Databases form a quantitative framework to leverage valuable external data, providing key development insights to maximize the probability of success for a new drug. Comparative effectiveness Endpoint and subpopulation relationships Biomarker efficacy and safety outcome Trial design optimization Competitive analysis and commercial viability Gathering, formatting, […]

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Quantitative Systems Pharmacology

QSP: Integrating Quantitative Drug Data with Knowledge of Its Mechanism of Action One of the biggest challenges—and, hence, the biggest opportunity for QSP—is drug attrition in Phase 2 clinical trials. Investigational medicines are usually tested for the first time in patients in Phase 2 clinical trials. This is the point when many drug programs fail. […]

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Clinical Trial Outcomes Databases

Clinical Trial Outcomes Databases Quantify Your Competitive Edge Along the development path of a compound, sponsors make critical decisions to ensure drug approval and market success. Success depends not only on the drug’s performance, but also on the competitive landscape, requiring reliable assessments—now and for the future—of your competition. Gain Faster Time to Insight What […]

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Model-based Meta-analysis

An Innovative Strategy to Make Better Use of Available Data The difference between getting a new medication to patients, and it ending up in the scrap heap of failed programs lies in making the right choices. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How […]

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Pharmacometrics

Crossing the Chasm: Pharmacometrics is a “Must Do” for a Successful Drug Program Successful drug development and commercialization requires getting critical decisions right—what is the exposure-response relationship for the drug, what is the optimal dosing strategy, and which patients would derive greatest benefit from it. Pharmacometrics uses mathematical and statistical models to quantify drug, disease, […]

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PK/PD Drug and Disease Modeling and Simulation

Quantifying Drug, Disease, and Trial Information to Aid Efficient Drug Development For almost 20 years, our pharmacometricians have combined insight and innovation to build quantitative models of the interactions between the human body, drug effects, and diseases. Our team develops models that are fit-for-purpose and meet strategic objectives, are aligned with regulatory authority requirements and […]

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