Regulatory agencies, including the US FDA, Japan Pharmaceutical and Medical Device Agency (PMDA), China Food and Drug Administration (CFDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), all use Phoenix WinNonlin to evaluate drug submissions. PK Submit, a new technology solution that automatically generates PK CDISC domains during NCA, available. Certara Integral, a new next-generation 21 CFR Part 11 compliant PK data repository, available as a plug-in to Phoenix. It is the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling with a proven 30-year history. 2) automatic slope selection with the same criterion of WinNonlin 3) supporting both linear-up linear-down and linear-up log-down method. Integrated Validation Suite for Phoenix NLME. Phoenix WinNonlin is used by over 6,000 scientists at more than 1,500 establishments in 60 countries. Phoenix WinNonlin™’s integrated tools for data processing, graphing & charting, report generation, and compliance create an efficient, all-in-one collaboration workbench. PK/PD and non-compartmental analyses can be time consuming, requiring detailed attention to every step from data preparation to report generation.
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