The current version of the database includes clinical safety and efficacy information on all biologics as well as newer synthetic DMARDs currently approved or in development for rheumatoid arthritis (RA). Information on older treatment options (MTX and other DMARDs) was included if they are used as active controls.
The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for Chronic Kidney Disease (CKD) progression
in patients with Type 2 Diabetes Mellitus (T2DM) and overt albuminuria/proteinuria, as well as patients with IGA nephropathy.
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.