PK/PD Analysis

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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