Phoenix

Phoenix® is Certara's industry-leading PK/PD analysis and modeling platform, trusted by preclinical scientists and clinical pharmacologists worldwide to make critical drug development decisions with confidence. Designed to support every stage of the drug development spectrum — from early preclinical evaluations through late-stage regulatory submissions — Phoenix delivers comprehensive tools for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) analysis, modeling, and reporting. With over 11,000 users across more than 2,600 companies, and more than 33,000 peer-reviewed articles citing the platform, Phoenix is widely recognized as the gold standard in PK/PD analysis.

Phoenix bridges the gap between discovery and clinical phases by enabling robust, scalable, and compliant analysis of PK and PD data across all application types. The platform empowers teams to answer pivotal development questions — such as whether to proceed to first-in-human studies, how to adjust dosing for age and weight, or whether to pursue an oral versus injectable formulation — even for the most complex drug modalities.

Core Analytical Capabilities

• Noncompartmental Analysis (NCA): Phoenix WinNonlin is the gold standard for NCA, offering precise analysis with flexible data handling, regulatory compliance, and intuitive visualization. It supports calculation of key parameters such as AUCs and generation of tables, figures, and listings (TFLs).
• Population PK/PD (NLME Modeling): Phoenix NLME enables evaluation of population-level PK and PD data using nonlinear mixed-effects (NLME) modeling through a modern, intuitive interface designed for today's pharmacometricians.
• In Vitro-In Vivo Correlation (IVIVC): Phoenix provides enhanced tools to seamlessly correlate in vitro dissolution data with in vivo performance, supporting formulation optimization and enabling a faster, more reliable path to biowaivers.
• Toxicokinetic (TK) Modeling: Supports toxicokinetic analysis alongside PK/PD workflows, covering the full range of preclinical and clinical data needs.

Platform Modules and Components

• Phoenix WinNonlin: The foundational module for NCA, PK/PD modeling, and TK modeling, taking analyses from raw data through to TFLs and final reports.
• Phoenix NLME: A modern pharmacokinetic and pharmacodynamic modeling software module that streamlines population-level analyses.
• Phoenix Hosted (Cloud): A cloud-based deployment that accelerates the journey from data ingestion to TFL and report generation, representing the gold standard for PK/PD analysis raised to the power of the cloud.
• Certara Integral: Included with Phoenix Hosted, Integral is an API-enabled data repository equipping PK scientists with support for both GxP and non-GxP studies.
• Pirana®: Provides a collaborative environment for managing and executing pharmacometric workflows, fully compatible with RsNLME.
• Trial Simulator: Helps prevent rejections in late-stage drug development and maximizes chances of success through advanced clinical trial simulation.
• Phoenix TFL Studio: A dedicated module for generating audit-ready tables, figures, and listings, reimagining how PK/PD data is visualized and reported with automation, traceability, and compliance built in.
• AI PK Reports: Leverages advanced artificial intelligence to automate PK report creation, transforming documents in minutes and enhancing both efficiency and accuracy.
• PK Dataset Preparation Tools: Dedicated tools to reduce the time and complexity involved in preparing and analyzing pharmacokinetic datasets.

Regulatory Adoption and Compliance

• Phoenix has been adopted by 11 global regulatory agencies, including the US FDA, ANVISA, DIGEMID, MHRA, Federal Institute for Drugs and Medical Devices, Medicines and Medical Devices Agency, Thailand FDA, NMPA, MFDS, PMDA, and the Therapeutic Goods Administration.
• The platform's modeling tools are validated and trusted by regulators, enabling sponsors to build rigor into their analyses and ensure regulatory compliance across submissions worldwide.
• Phoenix supports the full workflow from raw data to regulatory-ready reports, making it suitable for both GxP and non-GxP environments.

Who Phoenix Serves

• Preclinical scientists conducting toxicokinetic and early PK evaluations
• Clinical pharmacologists performing NCA and population PK analyses
• Pharmacometricians building and executing NLME models
• Formulation scientists working on IVIVC and biowaiver applications
• Biotech companies, large pharmaceutical organizations, and CROs across the drug development ecosystem
• Academic researchers and students — Certara offers free Phoenix desktop licenses for academic course instruction, as well as free Pirana and RsNLME licenses for academic use, with additional discounts on training and certification

Phoenix is available as both a desktop solution and a cloud-hosted platform (Phoenix Hosted), supporting flexible deployment to meet the needs of individual scientists and enterprise teams alike. The platform's broad regulatory adoption, extensive peer-reviewed citation record, and comprehensive suite of integrated modules make it the definitive choice for PK/PD analysis and modeling throughout the drug development lifecycle.