Drug Development Stewardship and Strategic Planning

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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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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PK/PD Analysis

PK/PD Support for Drug Approvals Pharmacometrics: From “nice to have” to “must have” technology Model informed drug development and discovery—which includes both top-down pharmacokinetic/pharmacodynamic (PK/PD) modeling and bottom-up, mechanistic approaches―continues to profoundly impact drug development by informing key decisions and labeling. Key benefits of this approach include: Making data-driven decisions at all stages of drug […]

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Pharmacometrics Regulatory Strategy

Predictive Disease-Drug-Trial Modeling and Simulation A well-designed pharmacometrics regulatory strategy satisfies multiple goals. First, the strategy prioritizes the needs of the program and details when and how they will be met. Next, a strategic road map provides direction that ensures that studies and analyses will be fit-for-purpose and add value to the program. Finally, a […]

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