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Clinical Development

Achieve your regulatory milestone faster with better decision-making and less re-work

The stakes are never higher than in the clinical phase of your drug development program – nearly 60% of drugs entering Phase III failing to achieve regulatory approval. By providing a longitudinal evaluation of disease-specific metabolic signatures during a trial, our Targeted Metabolomics Solution enhances monitoring of individual patient response to drug metabolism and toxicity, as well as provides improved post-approval drug monitoring.

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Inform adaptive trail design strategies and responses in real-time
Optimize eligibility criteria by proactively identifying responders/non-responders baseline characteristics
Dynamically monitor and optimize dose response by tracking prodromal signals of efficacy and safety
Maintain trial quality by monitoring patient compliance, subject outliers and potential food or drug-drug interactions
Strengthen post-market surveillance with a differentiated drug profile and competitor analysis

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Related Resources

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Repurposing eflornithine to treat a patient with a rare ODC1 gain-of-function variant disease

Repurposing eflornithine to treat a patient with a rare ODC1 gain-of-function variant disease

Five Translational Insights Key to a Successful First-in-Human (FIH) Study

Five Translational Insights Key to a Successful First-in-Human (FIH) Study

How United Therapeutics leverages metabolomics to get closer to the phenotype increasing confidence in clinical trial decisions

How United Therapeutics leverages metabolomics to get closer to the phenotype increasing confidence in clinical trial decisions

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Request a quote for our services or more information on sample types and handling procedures, need a letter of support, or simply have questions about how metabolomics can advance your research.

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    Metabolomics

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