Certara Integral is the company’s 21 CFR Part 11 compliant central data repository, which enables clients to store their models, study data and results in a validated environment ready for data mining and ultimately, submission. It also provides the necessary supporting documentation. PK Submit is Certara’s new Clinical Data Interchange Standards Consortium (CDISC) compliance tool, which ensures that all client data are stored in the CDISC formatted files required for FDA PK regulatory submissions. With Phoenix 8.2, users can now also access PK Submit™ and Certara Integral™ directly using Phoenix plug-ins. That detailed report allows scientists to quickly identify and rectify the source of any output variations.
PHOENIX WINNONLIN SOFTWARE PDF
Once the tests are complete, the NLME Validation Suite compares those results with reference output results and generates a non-editable PDF validation report with embedded links to csv files of outputs and differences in outputs. Kerbusch.Ĭertara’s Phoenix NLME Validation Suite is used by clients to run a series of standard test cases and validate the software in their own environment.
PHOENIX WINNONLIN SOFTWARE MANUAL
We have been able to run all 78 standard test cases in under 30 minutes, whereas manual validation can take weeks,” said Dr. “For instance, integrating Certara’s Nonlinear Mixed Effects Modeling (NLME™) Validation Suite into Phoenix will improve the speed and ease with which clients can complete the validation process tremendously, saving them both time and money. Of equal importance, our commitment to providing the regulated community with auditable data and methodology packages is evidenced in not just Phoenix, but across our product suite for pharmacometrics use in drug development,” said Thomas Kerbusch, PhD, President CSC at Certara.
Phoenix 8.2 includes key new capabilities that were developed in direct response to client feedback, delivering both faster performance and greater ease of use. “As the industry leader in leveraging modeling and simulation to improve decision making throughout the drug development process, Certara works to continually enhance our products to meet clients’ current needs and anticipate their future requirements.
More than 90% of all novel drugs approved by the US Food and Drug Administration (FDA) in the past four years are from companies that use Phoenix in their R&D programs. Phoenix is the most advanced and widely-used validated software for PK, PD, and toxicokinetic modeling and simulation worldwide. Certara®, the global model-informed drug development and decision support leader, on, announced the launch of Phoenix® 8.2, the industry gold standard in pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation software for drug development.