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NLME parallelization feature is available for most run modes and offers the ability to run on powerful remote compute platforms, reducing run times from days to minutes. Two major enhancements have been made in Phoenix NLME 8.0: automatic parallelization on remote grids, and the addition of a distributed delay function. Phoenix NLME 8.0-automatic parallelization and distributed delay function for modeling delayed outcomes It streamlines the validation process through automated tests accessed through a graphical user interface and validation document templates. Phoenix WinNonlin Validation Suite 8.0 provides objective evidence of Phoenix WinNonlin 8.0 functionality.
#CMA OBJECT IN PHOENIX WINNONLIN SOFTWARE#
This requires significant time and resources to manually write and perform the validation steps used in software execution. Validation Suite 8.0-integrated and fast validation for WinNonlin implementationĪs required by US FDA’s 21 CFR Part 11, the International Conference on Harmonization of Technical Requirements (ICH), EudraLex Annex 11, and other regulatory agency guidance documents, computer systems used in the pharmaceutical industry, and output from software used in regulatory submissions must be validated to assure proper performance. The new plasma, urine and custom-defined NCA parameters minimize post-processing work and increase transparency with analysis. Finally, users now can define custom NCA parameters, eg, those for computing concentrations used in interpolation methods, or other non-standard parameters such as half-C max value. These parameters, commonly requested by global regulatory agencies, are now integrated into Phoenix, eliminating the need to use data wizards or other third-party tools to calculate them. One of the more beneficial enhancements in WinNonlin is the new NCA parameters for plasma and urine that have been added to the standard output.
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The acceptance criteria display provides the ability to easily filter the subjects, or the profiles, that either meet or don’t meet the acceptance criteria. This setting is useful, for example, if you have a modified or extended release formulation and you want to ensure that the terminal slope is only calculated after a drug has been completely absorbed or absorption has stopped.Īnother new feature in WinNonlin is the ability to automatically flag values that are related to Lambda Z that may or may not meet your standard operating procedure (SOP) criteria, including the adjusted R 2, the observed or predicted % extrapolated area under the curve (AUC), and span (sampling interval/t 1/2). This new feature includes the ability to specify the maximum number of points to include in the regression and the earliest time for samples to be taken. Significant advances have been made to the Phoenix WinNonlin NCA engine, including the addition of new business rules for terminal slope (Lambda Z) which allows you to specify how it is calculated.
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Phoenix WinNonlin 8.0-taking NCA to a new level This blog post summarizes the key topics covered in the webinar-for a detailed overview, watch the webinar and read the latest volume of The Phoenix Reporter e-newsletter. Nathan Teuscher highlighted the new features and enhancements in the Phoenix WinNonlin ® non-compartmental analysis (NCA) engine, NLME, Validation Suite, and the Phoenix workbench. In a recent informative webinar and demo, Dr. Many of the new features and functions that have been implemented in Phoenix 8.0 are based on valuable feedback received in a survey given to our Phoenix community. In outlining the plan, the Commissioner endorses modeling and simulation approaches to increase the efficiency of drug development.Ĭertara has launched Phoenix ® 8.0, the latest version of the innovative PK/PD modeling and simulation software used globally by researchers and drug developers in pharma, academia, and regulatory agencies. Scott Gottlieb, the Commissioner of Food and Drugs, has outlined the steps the US FDA will take to implement the 21st Century Cures Act.