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