Tag: Clinical Pharmacology Strategy
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
In this webinar, Pau Aceves, Associate Director of Consulting Services at Certara, presented case studies on how tracer kinetics were used to inform development of new drugs for lung, CNS, and liver diseases. By watching this webinar, you will learn how tracer kinetics can leveraged for PK, PD, and in silico modeling applications.
Changing the Game, Optimizing Success, Increasing Value: Committed to scientific and regulatory advancement, Certara has integrated its capabilities to create impactful healthcare solutions.
This webinar introduced the importance of bioanalysis and its downstream effects on clinical development and clinical pharmacology.