Late Phase

Late Phase

You have successfully completed several early phase studies. Now XP Pharma Consulting works with you utilizing quantitative tools and strategies that facilitate successful data interpretation and reporting. We help you design pivotal studies that will generate the PK/PD data required to secure a successful clinical pharmacology package for NDA/BLA filing. We employ innovative modeling and simulation techniques to justify the doses in the labeling, avoid certain late-phase studies, build a bridge strategy to pediatric populations, simulate clinical studies under different scenarios, and more:

Noncompartmental PK Analysis (NCA):

• NCA analysis with validated software tools
• NCA analysis plan as part of study protocol or standalone
• NCA analysis results (tables, listings, and figures)
• NCA analysis results interpretation
• NCA PK exposure-response analysis
• Submission ready reports