Certara’s Phoenix® PK/PD Platform: Trusted Biosimulation for Confident Drug Development

What Is Phoenix PK/PD?

Phoenix® by Certara is the world’s most trusted software platform for pharmacokinetic (PK), pharmacodynamic (PD), toxicokinetic (TK), and in vitro–in vivo correlation (IVIVC) modeling. Used by top pharma, biotech, academia, and 11 global regulatory agencies, Phoenix transforms complex drug data into regulatory-compliant insights.

Clinically Trusted. Globally Validated.

As a clinician or medical researcher, your focus is patient-centric and data-driven. Phoenix supports that through:

• Validated analytical workflows that meet global regulatory expectations
• Transparent, auditable outputs for clinical study reports (CSRs), IBs, and submissions
• GCP- and 21 CFR Part 11–aligned processes
• ISO 27001–certified cloud-hosted option for compliant remote access

The platform is routinely used to support clinical trial design, exposure-response analysis, and dose justification—directly informing decisions that impact patient safety and therapeutic efficacy.

 Pediatric Use Cases: Precision in Vulnerable Populations

Phoenix enables dose modeling across populations, including neonates, pediatrics, and special populations:

• Tailored dosing strategies for diseases like pediatric epilepsy
• Translational modeling from adult datasets to support pediatric extrapolation
• Population PK (popPK) models accommodating age, weight, organ maturity, and co-medications

This reduces the need for redundant trials and strengthens the clinical rationale for pediatric indications and orphan disease studies.

Optimizing Clinical Study Interpretation

Phoenix is particularly valuable in:

• Analyzing complex clinical datasets, including sparse sampling designs
• Performing non-compartmental analysis (NCA) for early-phase PK characterization
• Supporting bioequivalence and bio-similarity assessments
• Developing and validating population PK/PD models using Phoenix NLME™

Results can be quickly translated into actionable reports with built-in statistical tools and visualizations—expediting timelines for medical review and regulatory filing.

Designed for Speed Without Sacrificing Scientific Rigor

Despite its power, Phoenix is designed for practical use in clinical settings:

• User-friendly interface with drag-and-drop workflows
• Rapid onboarding for clinical teams, including medical monitors and study physicians.
• Auto-generating submission-ready reports, streamlining medical writing
• Available via cloud, with SSO and centralized license control—perfect for distributed or CRO-partnered teams

Phoenix shortens turnaround time from data to decision, enabling your clinical teams to remain agile during high-stakes development phases.

If you work in translational science, clinical oversight, or regulatory strategy, Phoenix helps you make evidence-based, patient-centered decisions with confidence.

Book a demo with AKT Health: info@akthealth.com
Discover how Phoenix can streamline modeling workflows, enhance study design, and drive faster, smarter development decisions.