eCTD Templates Page
Explore the only eCTD template suite created by regulatory writers for regulatory writers. Learn more about our eCTD Templates.
Maximizing Oligonucleotide Therapeutic Development: How They Work Blog Post
This blog explains how oligonucleotide therapeutics work and compares them with small molecule and biologic drugs.
Evidence generation in Europe- How valuable is the French National administrative health data (SNDS) On-Demand Webinar
Watch this presentation to learn • Overview of the SNDS and the key working practices to access the database and ongoing SNDS developments • Similarities and differences between SNDS and other claims databases • Strengths and opportunities for HTAs and...
Blueprint for pandemic response: Focus on translational medicine, clinical pharmacology and pharmacometrics Publication
Perhaps the most important lesson learned from the COVID‐19 pandemic is that of preparedness. Enhanced surveillance systems for early threat detection will be crucial to maximizing response time for implementation of public health measures (...)
Model-informed Vaccine Development Page
For the past four years, Certara has been developing a robust, regulatory-ready QSP platform for assessing and managing immunogenicity (IG).
Secondary Intelligence Page
Certara’s Secondary Intelligence | Predict and analyze off-target risks in drug development for safer outcomes.
Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate Publication
As model‐informed drug development becomes an integral part of modern approaches to the discovery of new therapeutic entities and showing their safety and effectiveness, modalities of incorporating the paradigm into widespread practice require a revisit. Traditionally, modeling and simulation (M&S)...
Why Your Regulatory Writers Need eCTD Authoring Templates Blog Post
If you’ve heard about eCTD authoring template suites before, but you’re not sure what they do or whether they would be beneficial to your pharmaceutical company or CRO, you’ve come to the right place. Here I will explain what an...
PBPK modeling approaches to assess risks associated with bioequivalence in drug development On-Demand Webinar
In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting virtual bioequivalenceIVIVE-PBPK in biopharmaceuticsAn quantitative risk assessment approach for virtual bioequivalenceRole of inter-occasion variability and pharmacokinetic properties in virtual bioequivalence
