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:

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• 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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