PK/PD Support for New Drug Approval
Pharsight's consulting team provides high-quality, regulatory-compliant PK/PD analysis, biostatistics, and reporting that are the basis of your regulatory submission package. On more than 100 client engagements per year, we apply our world-class expertise and technology to support nonclinical and clinical study analysis for new drug approval.
- Preclinical PK/TK Analysis
- Clinical PK Study Analysis
- Biostatistics and Data Management
- IVIVC/Formulation Strategy
- Population PK
- Special Populations: Pediatrics
- Medical, Regulatory and Scientific Writing
- Timely, cost-effective results are delivered using validated versions of
Pharsight software - Formal, auditable SOPs and Quality Assurance processes
- Analysis and study results are often leveraged for downstream modeling
projects to support dose selection, trial design and program strategies