In this 30-minute webinar, you will learn about PK Submit, a new add-on to Phoenix WinNonlin that automates the creation of PK CDISC domains during NCA analysis. It can generate both Study Data Tabulation Model (SDTM) and Standard for Exchange of Nonclinical Data (SEND) datasets. PK Submit was designed to create the entire PK regulatory … Continued
Drug development is a global enterprise. One of the great things about working at Certara is the ability to learn from fantastic colleagues living around the world. My Swedish colleague, Dr. Eva Berglund, is a clinical pharmacologist who is now a Senior Director of Regulatory Strategy at Certara after spending a long and distinguished career … Continued
The ability to analyze and visualize sequence-activity relationships in proteins and peptides added to D360’s biologics toolkit for drug discovery research
The strategic expansion of Certara’s US Access practice provides clients with opportunities to confront increasing drug pricing and reimbursement challenges
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
Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued
PRINCETON, NJ – July 9, 2019 – Certara has formed a new practice area called Certara Global Health (CGH) to focus its technological expertise on helping to achieve equity in health for all people worldwide.
