The Quantify AS Clinical Outcomes Database is developed to document clinical safety and efficacy information from randomized controlled trials investigating biologics currently approved or in development for ankylosing spondylitis (AS).
The Quantify Acute Lymphoblastic Leukemia (ALL) Clinical Outcomes Database documents clinical efficacy information in infants, children, and adults following salvage treatment for relapsed/refractory patients.
The current version of the database includes clinical safety and efficacy information on all symptomatic drugs as well as newer Abeta drugs currently approved or in development for Alzheimer Disease (AD).
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.
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.