Drug Development and Clinical Pharmacology Strategy

Changing the Game in Drug Development through a Strategic and Programmatic Approach Far too many cases treat drug development like a relay race, with the baton handed from one participant to the next. But, this approach risks missing opportunities to develop medicines faster and better. And lacking a holistic and strategic roadmap to achieve milestones […]

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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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Contact Us

Sales Inquiries Interested in learning more? Please fill out the form and a representative will get back to you. Or, please contact us at any of our locations below: United States:  1-888-708-7444 or 1-919-852-4685 Germany:  +49 89 45 10 300 United Kingdom:  +44 (0) 114 460 0200 Australia:  +61 3 8610 6683 New Zealand:  +64 9 363 […]

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About Our Solutions

Cutting Edge Modeling and Simulation Solutions for Drug Development Drug development has become more complex and multi-layered. New combination therapies require more precise and individualized analyses, new approaches such as “basket studies” evaluate potential disease targets through a new lens, safety issues are more challenging, and comparative effectiveness plays an increasingly important role in “go/no […]

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