A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
Certara Optimize is a strategic and programmatic approach to drug development that leverages our expertise in drug development, clinical pharmacology, the use of quantitative analysis methods, and regulatory science to optimize decision-making.
The Phoenix IVIVC Toolkit provides enhanced tools for in vitro-in vivo correlation studies used by formulation and pharmaceutical scientists to improve the success of BE studies. The IVIVC Toolkit approach requires less assumptions, as compared to other methods, and helps the user define the correlation observed from real in vivo profiles as compared to the dissolution profiles.
In vitro-in vivo correlation (IVIVC) is an important, predictive mathematical tool in drug development, used to enhance product and process understanding with the ultimate goal of ensuring consistent performance throughout the product’s life cycle.
The Phoenix WinNonlin Validation Suite is a desktop application that provides objective evidence of Phoenix WinNonlin functionality and streamlines the validation process through the use of automated tests accessed through a graphical user interface and validation document templates.
A purpose-driven organization, d3 Medicine, now part of Certara, shares a commitment for putting the patient first and thinking differently: to accelerate drug development and optimize the use of new medicines.
Certara has developed the SEND Workflow Template for your Phoenix application. The Send Workflow Template prepares non-compartmental analysis (NCA) data in the format required by the FDA and other regulatory agencies for electronic submission.
Phoenix NLME is the PK/PD modeling software that is user-friendly and easy-to-learn. Built from the ground up on the Phoenix workbench architecture, Phoenix NLME enables users to focus on modeling, and not on the tools or coding required to implement the modeling. The result is more time for analysis and strategic decision-making.
D360 Express with ActivityBase connector is ideal for ActivityBase users who want quick and easy, single-point access to retrieve, analyze and share scientific data. It’s the only turnkey solution that seamlessly integrates ActivityBase with D360 Express to provide leading edge capabilities while minimizing IT cost and maintenance.
D360 Express is an out-of-the-box integrated solution specifically designed for discovery scientists at smaller pharmaceutical research organizations. It provides access, integration, analysis and visualization of scientific data from multiple data sources. D360 Express gets you up and running quickly and affordably.