Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset Announcement Certara 与韩国毒物学研究所合作,确保 SEND 数据集可供 FDA 提交使用 Software will aid optimizing pre-clinical data management in accordance with global standards and guidelines. Seoul,…Certara2023 年 8 月 3 日
Drug Manufacturers’ Recent Drop in Insulin Prices in the United States Blog 药品生产商最近降低美国胰岛素价格的情况 The prevalence of diabetes in the US is incredibly high and affects more than 10%…Certara2023 年 8 月 3 日
价值传播如何决定你的商业成功? 网络研讨会点播 价值传播如何决定你的商业成功? Are you struggling to effectively communicate the value of your products or services in today's…Danielle Pillsbury2023 年 8 月 2 日
Certara and Drugs for Neglected Diseases initiative (DNDi) Partnering to Fast-track Data Submissions and Accelerate Drug Approvals for Neglected Patients Announcement Certara 与被忽视疾病药物研发倡议组织(DNDi)合作,为被忽视患者快速提交数据并加速药物审批 DNDi Utilizing Pinnacle 21 Enterprise (P21E), Certara’s Data Science platform for Biostatistics, Data Management, and…Certara2023 年 7 月 31 日
以模型为依据的药物开发如何加速您的项目? 网络研讨会点播 以模型为依据的药物开发如何加速您的项目? What is model-informed drug development (MIDD), and why is it so critical to informing the…Danielle Pillsbury2023 年 7 月 28 日
ICER’s Unsupported Price Increase Report: Unfit for Policymaking White Paper ICER’s Unsupported Price Increase Report: Unfit for Policymaking Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported…Danielle Pillsbury2023 年 7 月 25 日
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling Publication 虚拟生物等效性研究中受试者内变异性分配的概念验证:利用基于生理学的药代动力学模型传播胃肠道生理学的受试者内变异 While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration…Danielle Pillsbury2023 年 7 月 21 日
Simcyp™ Compound Summaries Library: What is it & why should you use it? 博客 Simcyp™ 化合物摘要库:它是什么,为什么要使用它? In the world of pharmacokinetic/dynamic (PBPK/PD) modelling, compound PBPK models are incorporated into compound files…Certara2023 年 7 月 21 日
RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission On-Demand Webinar RAPS 赞助的网络广播:How to Plan for a Successful EMA Policy 0070 Submission In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to…Danielle Pillsbury2023 年 7 月 20 日
Change Management – An Important Part of Good Manufacturing Practice (GMP) Blog Change Management – An Important Part of Good Manufacturing Practice (GMP) You are having a good day as a quality assurance professional at a small pharmaceutical…Certara2023 年 7 月 14 日