By Eva Gil Berglund and Nathalie H Gosselin Oligonucleotide therapeutics are a validated class of drugs that can modulate a multitude of genetic targets with gene silencing to prevent expression of encoded “disease-related” proteins. Developing drugs in this class is challenging. That’s why we’ve put together this list of 8 clinical pharmacology and pharmacokinetic considerations … Continued
Tag: Clinical Pharmacology Strategy
This webinar will explain both common pitfalls that sponsors experience and how clinical pharmacology study execution and operational support can increase the efficiency of your Phase 1 studies and improve the quality of data collected.
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.
Certara uses a unique set of disciplines and technologies to address the challenges that infectious disease drug programs face.
Medicines Development for Global Health (MDGH), a not-for-profit biopharmaceutical company, needed integrated, model-informed drug development expertise to support developing a treatment for river blindness. Learn how Certara’s clinical pharmacology, pharmacometrics, and regulatory strategy expertise yielded a significant financial, scientific, and regulatory ROI to MDGH.
PRINCETON, NJ – July 9, 2019 – Certara has formed a new practice area called Certara Global Health (CGH) to focus its technological expertise on helping to achieve equity in health for all people worldwide.
This webinar described some important strategic considerations for successful development of complex biologics including appropriate data collection and timings, analyses requiring cross-functional data integration, and key pharmacology-related critical questions.
Apocalyptic clinical pharmacology helps drug developers save resources and time through providing a framework for understanding the interaction of the drug under development with the biological system. This framework also helps answer questions from regulatory authorities who are evaluating the safety and efficacy of the drug. Making informed decisions throughout the drug development process requires … Continued
As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Over the last couple of months, I’ve written a series of blog … Continued