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PK/PD Modeling and Simulation

Summit Analytical understands that Pharmacokinetics and Pharmacodynamics (PK/PD) are critical components in the drug development and approvals process. We provide extensive PK and PD experience and support, integrated with our biostatistics services. Our PK/PD modeling and simulation services can be tailored to provide standalone PK/PD services only or integrated fully integrated PK/PD services with biostatistics. We have the expertise and experience to deliver high quality PK/PD results needed for successful drug approvals, including:

  • Designing PK studies and sub-studies, including:

    • Single and multi-dose PK studies

    • Bioavailability and bioequivalence  (BA/BE) studies

    • Dose proportionality

    • Drug-drug, drug-disease studies

    • Sparse sampling regimens

    • Population PK studies

  • Development of PK/PD analysis plans

  • Perform PK and PK/PD analysis

  • Sparse sampling analysis

  • BA/BE analysis

  • Toxicokinetics

  • Population PK analysis

  • PK/PD modeling and simulation

  • PK/PD Report writing

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