Celerion’s team of clinical pharmacologists has extensive expertise in PK/PD data assessment and consults with clients on the appropriate analytical approach for clinical studies.
Additionally, the team conducts non-compartmental and compartmental PK/PD analyses using data derived from plasma, whole blood, urine and other potential physiologic matrices.
Celerion stays informed on best practices and industry standards to ensure consistent delivery of timely, high-quality analyses and reports. Celerion utilizes leading industry software such as WinNonlin® and other proprietary programs to provide the most accurate assessment of key PK parameters from studies on bioavailability, bioequivalence, food effect, drug-drug interactions, dose escalation and thorough QT studies.
Our scientists are committed to supporting the analysis and reporting of data through final approval and during regulatory review. Celerion complies with the evolving regulatory framework in all major markets, which enables us to address challenging questions from regulatory agencies from across the globe.
Comprehensive PK and PD services:
- Study design input
- PK and PD analysis and parameter calculation
- Written interpretation of PK and PD results for ICH study reports
- Consultation on PK/PD topics