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.
Modeling and simulation can help veterinarians provide better care for animals and guide research study design thereby maximizing the knowledge gained from research studies whilst minimizing the number of animals used. In this webinar, we looked at how PBPK modeling can be used to predict the absorption, distribution, metabolism, and excretion of drugs in humans and other animal species.
The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm on real-world evidence (RWE) and its adoption in the drug development process. While the collection of real-world data (RWD) and use of RWE is not new, they are now poised to have a profound impact on our industry. Today, it … Continued
PRINCETON, NJ – Mar. 13, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its pharmacokinetic/pharmacodynamic (PK/PD), quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modeling experts will participate in 21 sessions at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2019 … Continued
Last month, Health Canada announced an update to the mandatory use of the electronic Common Technical Document (eCTD) format. As with other agencies and regions, this helps move Health Canada towards a common submission intake process, as well as standardize and improve its business processes and tools. Previously, as of January 2018, New Drug Submission … Continued
PRINCETON, NJ – Mar. 8, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that it will be showcasing its multi-faceted – technology, service and regulatory science – approach to improving new drug safety assessments at the Society of Toxicology (SOT) Annual Meeting and … Continued
When developing a drug, pharmaceutical companies need to answer many questions to successfully undergo regulatory review and bring the drug to market. Apocalyptic clinical pharmacology is a framework that drug developers can use to uncover essential relationships between the drug dose and response or outcome. In other recent blog posts, I have covered what the … Continued
This webinar provided insights that could be used immediately in your development programs and could improve your readiness for deal and investment engagements.
PRINCETON, NJ – March 5, 2019 – Certara will partner with CDC to create OpenMDI (Open Medicolegal Death Investigation), a national system that will collect and share mortality data efficiently, allowing CDC to respond rapidly to critical public health priorities, such as tracking and understanding the toxicology behind drug overdoses from opioids.
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