Pharmacokinetics / Pharmacodynamics
Our team of pharmacokineticists is involved in the study design, data analysis and reporting aspects of the studies we run. All our clinical PK/PD services are conducted in accordance with FDA, Health Canada, EMA, and ICH guidelines and we routinely customize the outputs based on client requests (including the possibility of obtaining interim results).
Our PK/PD team is trained to be both GCP and GLP compliant:
- WinNonlin®v8 (Phoenix)
- Non-compartmental and compartmental analysis
- PK/PD modeling and simulation
- Development of a specific PK/PD analysis plan
- Interpretation of PK and PD outcomes
- Production of stand-alone PK/PD report
- Dose Escalation decisions/review (rapid turnaround in PK analysis and interpretation)
- PK/PD input into the protocol design and Clinical Study Report