Clinical Pharmacology

Clinical Pharmacology investigates the interaction between drugs and humans.

This requires in-depth knowledge on many aspects of drug development, i.e. (bio)chemistry, formulation development, (pre)clinical absorption/distribution/metabolism/excretion (ADME), pharmacokinetics (PK), pharmacodynamics (PD), pharmacogenomics and drug-drug interactions (DDI). 

The ultimate goal is to deliver the right dose to the right patient. By applying quantitative approaches (pharmacometrics, non-compartmental analysis (NCA)) and regulatory requirements, Clinical Pharmacology can determine the most efficient strategy within drug development.

Clinical Pharmacology applications can be…

  • Dose selection from First In Human (FIH) to Phase 3
  • Development & strategize the Clinical Pharmacology plan including:
    • FIH
    • bioequivalence (BE)
    • food effect
    • drug-drug interactions (DDI)
    • thorough QT (TQT)
    • special populations PK
    • ADME studies
  • Provide PK support for biopharmaceutical decisions throughout drug development
  • Contribute to regulatory submissions (i.e. briefing books, summary documents such as 2.7.1 and 2.7.2) and meetings
  • Support pediatric drug development (PSP or PIP)
  • Innovative clinical trial design and clinical trial simulations
  • PK analysis, interpretation and reporting of PK results from clinical trials
Want to know how Clinical Pharmacology can add to
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Pharmacometrics

Pharmacometrics uses models to describe the beneficial and adverse effects of a drug therapy on a patient.

Software

Developing and supporting open source tools that enable automated data handling, analysis, and reporting workflows.

Meet the experts

We are over 20 scientists with extensive experience located in the US and Europe. We work closely together and share knowledge to help our clients make better decisions.

Publications

Our succes in integrating information into models that generate unique insights, allowing executives to make better drug development decisions, is reflected in our gold-standard research publications.

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Get in touch
Mail
Phone (US)
+1 919 6519713
Phone (EU)
+46 70722 90 35
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