Certara scientists performed helped a small biotech company create a clinical pharmacology package for their NDA submission for a novel oncology drug.
A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.
The consortium members have partnered with Simcyp and Certara during the past 20 years to advance the science of drug development through modeling & simulation
This webinar discussed how to use a PBPK cancer population to investigate tumor disposition and therefore, impact on treatment regimens.
A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to better predict effective drug combinations, especially to more accurately correlate the physiological differences between preclinical models and human patients.
Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.