希少疾患における新たな治療薬の開発は、チャンスと複雑さの両方をもたらします。Because of the small patient pool available in these indications, there are challenges in designing and conducting clinical trials and the data interpretation that follows, and the ultimate path to registration. The top 3 critical downfalls in rare diseases development include Poor understanding of … Continued
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Unlocking Efficiency in Drug Development with Simcyp PBPK Modeling Complex drug-drug interactions (DDIs) are a significant roadblock in drug development. While crucial for safety, traditional methods like extensive clinical trials can be time-consuming, cost millions of dollars, and delay the delivery of potentially life-saving treatments to patients in need. This white paper introduces Simcyp PBPK … Continued
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
Learn how the FDA Modernization Act 2.0 will change the drug development landscape by allowing alternative methods to animal testing.
This white paper focuses on best practices for developing a CMC strategy for orally administered small molecule drugs
Model-Informed Formulation Development (MIFD) Increases Speed and Certainty for New and Generic Drugs
Understanding the European Union Clinical Trial Regulation 536/2014 (EU-CTR) While the new EU-CTR will help to streamline clinical trials, which will benefit both patients and researchers, there are some challenges for Sponsors adjusting to this new regulation. Certara’s depth of expertise and full suite of transparency and disclosure services allow us to help clients successfully … Continued
