Pharmacokinetic and Statistical Data Analysis
CEDRA performs pharmacokinetic and statistical analyses using SAS® and WinNonlin™ software. Concentration-time data acquired at CEDRA's bioanalytical facility (Part 11 compliant) are transferred directly from Watson™ LIMS System to WinNonlin™ for analysis. Pharmacokinetic and statistical services at CEDRA include:
- Pharmacokinetic and pharmacokinetic/pharmacodynamic modeling
- Non-compartmental analysis
- Bioequivalence and bioavailability testing
- Clinical pharmacokinetics
- Preclinical pharmacokinetics/toxicokinetics
- Determination of effects on dosing regimen and patient demographics on pharmacokinetics.
Pharmacokinetic and PK/PD Reports
CEDRA's pharmacokinetics team is experienced in developing formal Data Analysis Plans (DAP) or Statistical Analysis Plans (SAP) detailing study objectives, methods, and organization and representation of results. An analysis plan ensures that final reports address study protocol requisites and meet sponsor needs.
Biostatistical Services
- Design and implementation of randomization scheme
- Development of Statistical Analysis Plan (SAP)
- Sample size rationale and statistical power
- Methodology for summary and analysis of demographic, baseline, efficacy and safety data
- Description of statistical methodology
- SAS programming for tables, listings and figures
- Production of tables, listings and graphs in compliance with ICH guidelines
- Performance and validation of statistical analyses
- Interim analysis
- Bioequivalence
- Linear and non-linear modeling
- Parametric and non-parametric analysis of clinical and PK endpoints
- Production of statistical report/assistance with clinical report
- Statistical management throughout the project