Clinical

The clinical Pharmacologist provides pharmacokinetic (PK) and pharmacodynamic (PD) services ranging from integration of early development PK/PD data to design of the first-in-human (FIH) studies to proof-of-concept trials.

• Non-clinical support of clinical trial-enabling studies with focus on PK, PK/PD, TK, drug metabolism, drug-drug interaction (DDI) and bioanalysis
• Predictions of human PK (in vivo-in vitro extrapolation, allometry and physiological based-pharmacokinetics)
• Summarize non-clinical and clinical PK sections in the IMPD and IB documentation
• Support, participation in, and preparation of data for, meetings with regulatory authorities
• Design of FIH studies with adaptive design and dose setting
• Production of interim reports based on of blinded data and participation in regular safety committee meetings in dose escalation studies
• PK and PK/PD calculations (WinNonlin), modelling and simulation, and reporting
• Design of metabolites in safety testing (MIST) studies and strategies
• Design of phase I studies such as bioavailability, bioequivalence, biosimilar, DDI, EPQT, renal and hepatic impairment, human ADME, PET and MRI studies.
• Design of biomarker strategies and Phase IIa studies
• Microdosing (PET and microdialysis) and local administration of drugs in various organs.