PK/PD data comes from multiple sources, making it challenging to efficiently search, visualize, and analyze your data, and remain compliant for regulatory submissions. Especially with the large volumes of PK/PD data required for today’s complex clinical trials. With Certara’s Integral data and model repository, you’ll streamline your PK/PD workflows and ensure compliance with regulatory requirements &hellip; <a href="https://www.certara.com/webinar/october-learn-how-certaras-integral-streamlines-pk-pd-workflows-amp-ensures-compliance-with-regulatory-requirements/">Continued</a>

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>

Comparing your drug and the competition in terms of efficacy and safety data in the targeted therapeutic area is critically essential for optimizing development strategies and maximizing the value of a new drug. Model-based meta-analysis (MBMA) with clinical outcome database of publications and external information has been utilized to optimize trial design in recent years. &hellip; <a href="https://www.certara.com/webinar/adopting-mbma-with-clinical-outcome-database-powered-by-ai-technologies-japanese-webinar/">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

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

The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization. ICER’s mission is to conduct evidence-based reviews of healthcare interventions that help guide patients, doctors, and payers to high-value, cost-effective treatments using rigorous, transparent methods. ICER was founded in 2006 by Steve Pearson, a former fellow at the Americas Health … Continued