ADNCA Explained: The Next Generation of Non-Compartmental Analysis and the Top Questions Answered Blog ADNCA 解析:下一代非房室分析及其核心问题解答 ADNCA is transforming non-compartmental analysis by standardizing workflows, enhancing regulatory confidence, and enabling scalable automation.…Certara2025 年 7 月 23 日
Accelerating Oncology Drug FDA RTOR Submission with Project Management Services Case Study 通过项目管理服务加速肿瘤药物 FDA RTOR 申报流程 Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…Certara2025 年 7 月 2 日
The Medicine Maker: The Biosimulation Generation Press Coverage 药物制造者:生物模拟时代 The article, The Biosimulation Generation, explores the transformative potential of biosimulation in pharmaceutical R&D as…Danielle Pillsbury2025 年 7 月 1 日
5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address Blog 5 大临床开发挑战 — 基于模型的荟萃分析(MBMA)助力应对 2025 年 6 月 30 日 Drug development is increasingly defined by its complexity. Teams must navigate rising…Certara2025 年 6 月 30 日
Increasing Productivity In Pharma R&D Starts With Data Press Coverage 提升医药研发效率,从数据出发 This article discusses the growing volume of raw data collected during clinical research, and how…Certara2025 年 6 月 25 日
Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning Publication 建模与模拟及真实世界证据在临床试验多样性规划中的关键作用:挑战应对策略 Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…Danielle Pillsbury2025 年 6 月 19 日
Modernizing NCA Workflows: The Power of ADNCA for Regulatory-Ready Pharmacokinetic Analysis On-Demand Webinar 革新传统 NCA 流程:ADNCA 技术助力合规化药代动力学分析 Certara2025 年 6 月 11 日
Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer Publication Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…Certara2025 年 6 月 8 日
Explore First: How a Stepwise Approach to QTc Studies Reduces Time, Cost, and Regulatory Risk On-Demand Webinar 探索先行:分阶段 QTc 研究策略如何减少时间、成本及监管风险 Learn how a stepwise C-QTc approach can streamline cardiac safety evaluation, reduce costs, and align…Certara2025 年 5 月 5 日
MIDD’s Growing Role in Global Health: A Case Study of Primaquine Exposures in Lactating Women and Breastfed Infants On-Demand Webinar MIDD 在全球健康领域的作用日益增强:哺乳期妇女和母乳喂养婴儿伯氨喹暴露情况案例研究 Explore how model-informed drug development (MIDD) enhanced clinical lactation studies and supported global health policy…Certara2025 年 3 月 28 日