The state of gene therapy faces much uncertainty as recent regulatory and clinical setbacks have raised questions about its promise. With only two gene therapies FDA-approved for rare diseases to date, the path to developing these medicines is still a...
Oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases— are experiencing tremendous growth in the pharmaceutical industry. But, performing the needed PK/PD and clinical pharmacology assessments to optimize the safety and efficacy...
Explore the only eCTD template suite created by regulatory writers for regulatory writers. Learn more about our eCTD Templates.
This blog explains how oligonucleotide therapeutics work and compares them with small molecule and biologic drugs.
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...
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 (...)
For the past four years, Certara has been developing a robust, regulatory-ready QSP platform for assessing and managing immunogenicity (IG).
Certara’s Secondary Intelligence | Predict and analyze off-target risks in drug development for safer outcomes.
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)...
© 2025 Certara. All Rights Reserved. | Privacy policy
