The Pharmacokineticists provide pharmacokinetic and pharmacodynamic services ranging from the integration of early development PK/PD data to the design of first-in-human studies to proof-of-concept trials.
- Input on study design and dose setting
- Support, participation and preparation of data for meetings with regulatory authorities
- Perform interim reports of blinded data and participate in regular safety committee meetings in dose escalation studies.
- Pharmacokinetic calculations including PK/PD