PK/PD Analysis
Pharmacokinetic/Pharmacodynamic Analysis
Pharmacokinetic Experience
- Multiple Therapeutic Areas including Gastroenterology, Infectious Disease, Oncology,and Ophthalmology
- Development and Delivery of Pharmacokinetic and Safety Report
- Standardized PK Datasets in SDTM and ADaM Formats
Study Types
- Single and Multiple Ascending Dose
- Patients and Healthy Normal Volunteers
- Bioequivalence Trials
Modeling
- Phoenix™ WinNonlin®
- Non-Compartmental Estimation
- Two-Compartmental Estimation
- Dose Proportionality Assessments
- Standard Handling of BLQ with Sensitivity Analyses
In this case study, see how SDC managed expedited PK timelines for a 19-week clinical trial.