Juvenile toxicity studies considerations – not just “mini” general tox!

Outlining a pediatric clinical and safety assessment plan for investigational drugs is a required part of drug development due to regulatory legislation. These plans may include juvenile toxicity studies in animals to ensure safe and effective medicines for children. Juvenile toxicity studies are warranted when safety concerns can’t be adequately, ethically, or safely assessed in … Continued

Model-based meta-analysis for comparative efficacy and safety of therapeutics for COVID-19

Certara is launching the COVID-19 Clinical Outcomes Database, funded by the COVID-19 Therapeutics Accelerator. The Database includes observational studies and clinical trials with more than 10 patients that evaluate specific treatment options to improve disease outcome. It captures all patient characteristics, safety and efficacy outcomes, biomarkers and viral load data. The database also includes studies (>100 patients) that evaluate patient characteristics stratified by disease outcome such as death, or progression to severe or critical disease and studies (>10 patients) that report the time course of viral load, vital signs, and biomarkers.

Accelerating Therapeutics for COVID-19

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.

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