2739 results

The Value of Modeling and Simulation in Vaccine Development

A quantitative modeling approach can be used to predict the optimal time to administer influenza vaccine during pregnancy to provide protection to infants at birth.

https://www.certara.com/blog/the-value-of-modeling-and-simulation-in-vaccine-development/

Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

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

https://www.certara.com/blog/optimize-immuno-oncology-drug-discovery-and-development-using-quantitative-systems-pharmacology-2/

Spotlight on the PAGE Student Sponsorship Winners 2019

Read this blog profiling the student scholarship winners for the 28th annual meeting for the Population Approach Group in Europe (PAGE).

https://www.certara.com/blog/spotlight-on-the-page-student-sponsorship-winners-2019/

Trends for Market Access, HEOR, and Real World Evidence

This blog reviews trends for using health economics and outcomes research and real-world evidence to evaluate the value of medicines and health technologies.

https://www.certara.com/blog/trends-for-market-access-heor-and-real-world-evidence/

Achieving Compliance with the FDA’s eCTD Mandate

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, … Continued

https://www.certara.com/blog/achieving-compliance-with-the-fdas-ectd-mandate/
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