Pharmacokinetic and Statistical Data Analysis
Pharmacokinetic and statistical services at CEDRA include:
- Pharmacokinetic and pharmacokinetic/pharmacodynamic modeling
- Noncompartmental analysis
- Bioequivalence and bioavailability testing
- Clinical pharmacokinetics
- Preclinical pharmacokinetics/toxicokinetics
- Determination of effects of dose, formulation, dosing regimen,
drug interactions, genotype, gender, and other factors on pharmacokinetics - Reports for regulatory submission
Pharmacokinetic and Statistical Methodology
Our team performs pharmacokinetic and statistical analyses using SAS® and WinNonlin software. Concentration-time data are transferred (Part 11 compliant) directly from Watson™ LIMS System to WinNonlin™ for analysis.
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 insures that final reports address study protocol requisites and meet sponsor needs.
Biostatistical Services
- CRF Review
- 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, 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
