Accelerate Drug Development with Phoenix WinNonlin 8.4

Phoenix WinNonlin 8.4 is the world's leading software platform for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data analysis, forming the computational core of modern drug development. As part of Certara's integrated Phoenix platform, it is the regulatory and industry standard used by pharmaceutical and biotechnology companies to analyze how drugs move through and affect the body. From early non-compartmental analysis (NCA) of first-in-human trials to complex population PK/PD modeling, WinNonlin provides the robust, validated tools necessary to make critical decisions about dosing, safety, and efficacy, and to prepare submission-ready reports for global health authorities like the FDA and EMA.

Core Functional Capabilities of WinNonlin 8.4

• Comprehensive Non-Compartmental Analysis (NCA)
  Perform the foundational PK analysis for most clinical studies. Automatically calculate essential parameters such as AUC (Area Under the Curve), Cmax, Tmax, half-life, clearance, and volume of distribution from plasma concentration-time data. This is the standard method for bioavailability (BA) and bioequivalence (BE) studies.

• Advanced Compartmental Modeling & Curve Fitting
  Build and fit mechanistic PK/PD models. Use a library of built-in models or create custom differential equation-based models to describe drug absorption, distribution, metabolism, and excretion (ADME), as well as the relationship between drug concentration and effect (PD).

• Bioavailability & Bioequivalence (BA/BE) Toolkit
  Streamline regulatory submissions for generic and reformulated drugs. The software includes specialized workflows and statistical tools for conducting BA/BE studies, generating summary tables, and performing ANOVA and equivalence testing (90% confidence intervals) required by regulators.

• Integrated Workflow within the Phoenix Platform
  Connect analysis to wider modeling & simulation. As part of the Phoenix suite, data and models seamlessly flow between WinNonlin and other modules like Phoenix NLME for population PK/PD analysis and Phoenix Connect for automation and reporting, creating a complete end-to-end pharmacometrics solution.