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Pharmacokinetics/Pharmacodynamics (PK/PD)

PK/PD analysis for supporting investigational medicine studies  

Insightful Analysis: Clinical PK/PD

Our team of clinical pharmacologists has extensive expertise in PK/PD data assessment and consults with you on the appropriate investigative approach for your study. Our experts conduct non-compartmental and compartmental PK/PD analyses using data derived from plasma, whole blood, urine and other biological matrices. These analyses enable you to evaluate the risks of your drug, so you can make informed decisions and timely adjustments to your clinical program.

At Celerion, we stay informed on best practices and industry standards to ensure consistent delivery of timely, high-quality analyses and reports. We utilize industry-leading software such as Phoenix WinNonlin® and other proprietary programs to provide the most accurate assessment of key PK parameters from studies on bioavailability, bioequivalence, food effect, drug-drug interactions, dose escalation, ADME, and thorough QT.

Our scientists are committed to supporting the analysis and reporting of data through final approval and during regulatory review. We comply with the evolving regulatory frameworks in all major markets, enabling us to address challenging questions from regulatory agencies across the globe.

Study design input, PK and PD analysis and consultation, and written interpretation of PK and PD results for ICH study reports round out our comprehensive service offering.

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