Phoenix PK/PD logo

Phoenix PK/PD

by Certara β€’ certara.com
VISIT OFFICIAL WEBSITE β†’

OVERVIEW

The industry-leading platform for pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation, trusted by global regulatory agencies.

Phoenix is the world's most trusted software platform for comprehensive PK/PD, toxicokinetic (TK), and in vitro–in vivo correlation (IVIVC) modeling and simulation. It is the industry gold standard, used by over 2,600 companies and 11,000 users worldwide, with companies using Phoenix accounting for 90% of novel drugs approved by the US FDA.

The platform, which includes core modules like Phoenix WinNonlin (for Noncompartmental Analysis) and Phoenix NLME (for Non-Linear Mixed Effects/Population PK/PD), provides an all-in-one collaboration workbench for scientists, reviewers, medical writers, and quality assurance teams. Key capabilities include Noncompartmental Analysis (NCA), Population PK/PD modeling (NLME) with sophisticated algorithms, and Bioequivalence/Bioavailability studies.

Phoenix is designed for regulatory compliance, featuring validated analytical workflows, transparent and auditable outputs, and alignment with FDA 21 CFR Part 11, GCP, and CDISC standards. The software is available as a traditional desktop application and a cloud-hosted solution (Phoenix Hosted) that offers Single Sign-On (SSO), centralized access control, and reduced IT burden. It expedites workflows from data preparation to generating submission-ready Tables, Figures, and Listings (TFLs).

RATING & STATS

Customers
1,000+
Founded
2008

KEY FEATURES

  • βœ“Noncompartmental Analysis (NCA)
  • βœ“Population PK/PD Modeling (NLME)
  • βœ“Toxicokinetic (TK) Modeling
  • βœ“Bioequivalence/Bioavailability Analysis
  • βœ“Automated Validation Suite (21 CFR Part 11)
  • βœ“Visual Workflow Interface
  • βœ“Tables, Figures, and Listings (TFL) Generation

PRICING

Model: enterprise
Licensing is subscription or license-fee based and is not publicly disclosed. Academic and regional discounts are available for training and some licenses.

TECHNICAL DETAILS

Deployment: cloud, on_premise
Platforms: web, windows
πŸ”Œ API Available

USE CASES

Preclinical and Toxicokinetic AnalysisClinical Trial Design and OptimizationRegulatory Submission (FDA, EMA, PMDA)Dose Justification and LabelingBioequivalence and Bio-similarity Assessment

INTEGRATIONS

Certara Integral (Data Repository)PK Submit (CDISC Compliance)Watson LIMS (via Phoenix Connect)

COMPLIANCE & SECURITY

Compliance:
FDA 21 CFR Part 11ISO 27001GCPCDISC
Security Features:
  • πŸ”’Single Sign-On (SSO)
  • πŸ”’Centralized Authentication
  • πŸ”’Audit Trails
  • πŸ”’Robust Security Controls

SUPPORT & IMPLEMENTATION

Support: email, phone, training, user forum
Target Company Size: medium, enterprise
TRAINING AVAILABLE

PROS & CONS

βœ“ Pros:
  • +Industry-standard for PK/PD analysis, trusted by 11 global regulatory agencies
  • +Full compliance with FDA 21 CFR Part 11, GCP, and CDISC standards
  • +Integrated platform for NCA, PopPK, TK, and IVIVC modeling
  • +Intuitive graphical user interface with reusable, auditable workflows
  • +Cloud-hosted option (Phoenix Hosted) with SSO and reduced IT burden
βœ— Cons:
  • -High enterprise cost (not publicly disclosed)
  • -Steep learning curve for new pharmacometricians
  • -Proprietary software with limited customization outside of the platform's tools

ABOUT CERTARA