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.
At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and unlock millions of dollars in R&D savings.
Phoenix WinNonlin 8.0 takes non-compartmental analysis (NCA) to a new level by adding many new features to minimize post-processing work and increase transparency with analysis. Additionally, a new validation suite is embedded within the Phoenix 8.0 application and provides an affordable, turnkey process that is significantly faster than other validation options.
Phoenix 8.0 continues to set the gold standard in PK/PD software by delivering innovative features that streamline PK/PD analysis and outcomes, saving time, reducing errors, and providing regulatory agencies with more transparency into the analytical process.
Phoenix NLME in Phoenix 8 Beta features parallelization for almost all run modes and the ability to run on powerful remote compute platforms, reducing run times from days to minutes.
As the process of drug development has increased in cost and complexity, Certara has developed a service offering to assess a sponsors’ development program across multiple domains, and to craft a strategy to address each.
Physiologically-based Pharmacokinetic (PBPK) models describe and predict the handling of drugs by the body in a realistic way based on demography, physiology, biochemistry, and genetics. We integrate this information with in vitro drug absorption, metabolism, and transport data to simulate and predict in vivo pharmacokinetics in virtual patient populations.
Recognizing the great importance of serving pediatrics balanced against the inherent hurdles, Certara Nurture offers comprehensive pediatric drug development services.
Certara’s Compute Grid allows you to access up to 1,800 cores in the cloud with just one click, significantly accelerating model runs. Projects that took days can now be completed in hours or even minutes, affordably and without IT support.