A QSP model was built to evaluate its use in drug discovery for complex neurodegenerative diseases, e.g. Alzheimer’s.
This webinar will explain lessons learned from preparing for and responding to viral outbreaks such as H5N1 and pH1N1 influenza and discuss how insights from model-informed drug development approaches can spur access to medicines for patients.
Dr. Steven Kern - Deputy Director of Quantitative Sciences - Bill & Melinda Gates Foundation,
Dr. Craig Rayner - President of Integrated Drug Development - Certara
Dr. Fran Brown - SVP of Integrated Drug Development - Certara
This blog discusses the development of pharmacokinetic CDISC data standards and the impact of building them for electronic regulatory submissions.
This webinar will explain how Certara expanded its PBPK Simcyp Simulator to incorporate an extensive dermal model— MPML MechDermA, a multi-phase, multi-dimensional dermal absorption model.
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.
“Come senators, congressmen Please heed the call Don’t stand in the doorway Don’t block up the hall For he that gets hurt Will be he who has stalled” Bob Dylan recorded his iconic “The Times They Are a Changin’” in 1963; the song was released on the 1964 album by the same name. One of […]
High prices for drugs for rare diseases have introduced uncertainties from payers around whether a medication’s value justifies its price.
Model-based meta-analysis is a quantitative framework that uses PK/PD and statistical modeling of external data to inform drug development decisions.