Due to the rapid and continuous physiological changes during growth and development, pediatric patients cannot be treated as “small adults.”These physiological and molecular differences include body composition (height and weight), organ function and size, receptor response (pathway, safety), and maturation of absorption, distribution, metabolism, and excretion (ADME) changes. In addition to ontogeny considerations, pediatric … Continued
Bispecific antibodies (bsAbs) have become an integral component of the therapeutic research strategy to treat cancer. In addition to clinically validated immune cell re‐targeting, bsAbs are being designed for tumor targeting and as dual immune modulators. Explorative preclinical and emerging clinical data indicate potential for enhanced efficacy and reduced systemic toxicity. However, bsAbs are a … Continued
PBPK modeling using a virtual oncology population can help to predict exposure and accelerate the development of safe and efficacious oncology drugs.
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.
Immuno-oncology – The Breakthrough in Cancer Therapeutics Cancer immuno-oncology (IO) uses the body’s natural defenses to combat cancer. These therapies stimulate an individual’s immune system and restore its ability to identify and destroy cancer cells. Anti-cancer immune responses are often inhibited during the spread of cancer. Ultimately, IO therapy expedites long term responses against cancer … Continued