Discover Simcyp Biopharmaceutics, our latest addition to the Simcyp suite of technologies. This software empowers drug formulation scientists with advanced model-informed formulation development (MIFD) technology. As a proud member of the Simcyp family, Simcyp Biopharmaceutics provides a robust workbench for formulation development and optimization, maintaining the Simcyp gold standard for unparalleled formulation success. Join us &hellip; <a href="https://www.certara.com/webinar/explore-the-future-of-formulation-with-simcyp-biopharmaceutics/">Continued</a>

Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications. Efficient clinical pharmacology review of a marketing application requires early and thoughtful consideration of the development plan, timely conduct of &hellip; <a href="https://www.certara.com/webinar/clinical-pharmacology-issues-that-can-lead-to-approvability-problems-for-your-drug/">Continued</a>

Plain language regulatory requirements have recently come into effect for the EU and UK. This webcast will provide an overview of both the regulations and guidance around plain language summaries (PLS) and other documents. The webcast will also look at the “why” behind plain language regulations and how they can be used for patient engagement &hellip; <a href="https://www.certara.com/webinar/raps-sponsored-webcast-plain-language-summaries-understanding-the-why-behind-the-regulations-and-guidance/">Continued</a>

Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported Price Increase (UPI) Report on its “assessment on drugs that experience significant price hikes without any novel clinical evidence” to guide policy making on prescription drugs. US lawmakers have shown interest in the UPI approach as a potential tool to … Continued

Physiologically-based pharmacokinetic (PBPK) modeling has proven invaluable in drug development, especially for pediatric populations, because of its ability to reduce and potentially eliminate the need to conduct clinical trials in this special population. However, much of the early research into pediatric PBPK models has concentrated on the North European and American populations. Growing interest in … Continued

Many drug developers have products that they want to submit for marketing approval in several regions like the US (NDA/BLA), Europe (MAA (Marketing Authorization Applications)), Canada (NDS (New Drug Submissions)), and elsewhere. But developing each submission independently can waste a lot of time and money. Fortunately, there are ways to maximize the reusability of your … Continued

Who would have thought when we completed work on the first submission for which we ever authored 3 or more documents and provided strategic support (our criteria for saying that we supported a client’s submission), that we’d be celebrating our 300th such submission just 12 years later.  From that humble beginning, we’ve now supported more … Continued