The virtual twin approach combines limited clinical data with biological principles to make patient level predictions which could help recover halted trials.
This blog explains how Clarus Therapeutics utilized M&S to improve their Phase 3 study design and ultimately gain FDA approval for their product.
By Yuancheng Chen, Research Associate of Phase 1 Unit, Huashan Hospital, Fudan University, and visiting scholar of Uppsala University Certara recently held its first virtual Phoenix User Group meeting in China. Over this three-day meeting, attendees learned from Certara’s experts on specific Phoenix workflow examples, updates to the Phoenix product roadmap, an overview the latest … Continued
This blog explains how model-informed drug development (MIDD) can inform and accelerate a COVID-19 therapeutics program.
3 key tips to set your pediatric program up for success with the RACE for Children Act by Lynne Georgopoulos, RN, MSHS, RAC, Vice President, Regulatory Strategy at Certara On August 18, 2020, the Research to Accelerate Cures and Equity (RACE), which amends the Pediatric Research and Equity Act (PREA) comes into effect. With the … Continued
Modeling and simulation were used to optimize a sponsor’s Phase 3 clinical trial study design to achieve efficacy and safety goals as well as regulatory approval.
This blog asks and answers 10 critical drug development questions whether you have a new molecular entity or are repurposing a drug already in clinical use.
Henri Merdjan explains why topical drug formulations (e.g. intranasal and/or oral) could be valuable as a therapeutic option for COVID-19 patients.
Clinical pharmacology provides a valuable opportunity to accelerate the near-term development of existing repurposed drugs for COVID-19 treatment and therapy.
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.