Category: 网络研讨会点播

自 FDA 颁布法规要求递交的数据集需符合 CDISC 研究数据制表模型（SDTM）以来，临床试验申办方一直面临着一个难题。他们应该从一开始就按照 SDTM 设计电子病历报告表（eCRFs）吗？还是应该在最后阶段再将数据回溯性地转换为 CDISC SDTM？A retrospective … Continued

人工智能模型和 GPTs 的普及彻底改变了生命科学行业消费信息和利用信息从而加速和验证研究的方式。利用 GPTs，研究人员可以在几分钟或几小时内完成通常需要数周时间的文献查阅和数据提取任务。In this webinar, Certara’s experts will … Continued

Even if the product is the same, the applications for marketing authorization in Europe and the United States can look very different. This presentation will explore the major differences between EMA marketing applications (MAAs) and U.S. FDA marketing applications (NDAs/BLAs), strategies for publishing in tandem, and even means to “clone” sections for efficiency. Tips for … Continued

The proliferation of powerful AI models, including GPTs, has revolutionized how the life sciences industry consumes information and uses it for accelerating and validating research. For example, by leveraging GPTs researchers can complete what would normally be weeks long literature review and data extraction tasks in a matter of minutes or hours. In addition, these … Continued

本网络研讨会由国际药物统计学会（ISoP）主办 演讲者：；摘要;；针对 BAFF 和 APRIL 的治疗性拮抗剂治疗自身免疫性疾病的开发仍处于起步阶段，关于其作用机制和药效学（PD）特征以及如何优化其疗效仍存在许多问题。We developed a quantitative systems … Continued

Already the most sophisticated technology for physiologically based pharmacokinetic modeling (PBPK), the Simcyp Simulator has added a range of new advances in its recently release (version 23).  This webinar, hosted by the subject matter expert scientists at Simcyp, will share these new capabilities and review the features that have enabled the Simulator to be leveraged … Continued

在我们即将举行的网络研讨会上了解 Phoenix 8.5 版本的最新进展和增强功能。了解关键的发布主题，包括通过改进表格、绘图和报告模块对报告功能的重大升级。了解利用 Certara CentralAdministration 简化许可流程的情况，并探索 NLME 增强功能，增强您的建模和模拟能力。… Continued

Drug developers face increasing pressures to accelerate the drug development process, including reducing submission timelines. Organizations are answering the challenge by evolving their authoring processes and leveraging technology efficiencies. For example, lean authoring techniques that incorporate structured content reuse can streamline the creation of complex regulatory documents. Tools that incorporate generative artificial intelligence (AI) can … Continued

Unlock the full potential of your pharmacometric analysis with our introductory webinar on Pirana, the premier platform designed to enhance efficiency, organization, and performance in your pharmacometrics projects. Whether you’re new to Pirana or looking to optimize your workflow, this session is your first step towards mastering the tools and techniques that will transform your … Continued

Dr. Johan Gabrielsson 因《药代动力学和药效学数据分析》（Pharmacokinetic and Pharmacodynamic Data Analysis）一书而闻名，他与来自 Certara 的 Dr. Bernd Wendt和 Dr. Keith Nieforth 合作编写了即将发行的第 6 版。新版引入了关于使用非线性混合效应模型进行群体分析的创新章节，并通过实际案例研究加以强化。Drs. Gabrielsson and Wendt will co-present a … Continued