罕见病的新疗法开发既是机遇，也很复杂。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
自 2019 年以来，临床与经济审查研究所（ICER）每年都会发布一份《Unsupported Price Increase (UPI) Report ，介绍其 "在没有任何新临床证据的情况下对大幅涨价药物的评估"，以指导处方药的政策制定。美国立法者对 UPI 方法表现出了兴趣，将其作为一种潜在的工具来...Continued
了解 FDA 现代化法案 2.0 将如何通过允许动物试验的替代方法来改变药物研发格局。
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
