11 Coventry Ln,
Stoneham, MA 02180

Early Phase

Early Phase

XP Pharma Consulting works with you to create plans to ensure that each study fits with your overall drug development program and facilitates efficient and timely data generation, analysis, and reporting. We offer the following services

Noncompartmental PK Analysis (NCA)

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

PK/PD Modeling & Simulation

  • Population PK analysis
  • PK exposure-response (E-R) analysis
  • Concentration-QT analysis and modeling
  • Dose selection and justification
  • Identify predictive covariates for late phase PK/PD design.
  • Dose simulations for different populations and formulations
  • Submission-ready reports authoring

Clinical Pharmacology Strategy and Writing

  • Gap analyses and mitigation strategy
  • Clinical pharmacology plans
  • Clinical Study protocols (in full or in part)
  • Inclusion/exclusion criteria
  • Clinical Study reports and/or standalone PK report
  • Regulation document preparations (PK/PD)
  • Responses to regulatory questions (in full or in part) and reviews
  • Regulatory meeting representations
  • Dose rationale and justification
  • PK/PD design in the study protocols
  • Comparator PK/PD data analyses
  • Assessment of Drug-drug interaction (DDI) potential
Contact us today to discuss how we can help you

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