De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development Blog 降低药物开发风险:早期开发中的关键化学、制造和控制(CMC)及基于生理的药代动力学(PBPK)方法 2024 年 11 月 22 日 In drug development, early strategic planning is crucial to minimizing risks, optimizing…Certara2024 年 11 月 22 日
A Medical Writer’s Guide to Collaborative Authoring Blog 医学撰稿人协作创作指南 Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…Certara2024 年 11 月 22 日
Top Three Insights from Certainty Europe Blog Certainty Europe 带来的三大洞见 The first European Certainty Conference for the Certara Client Community in Mainz Germany was full…Certara2024 年 11 月 21 日
Mastering Value Storytelling with Data-Driven Stories Blog 以数据驱动的故事精通价值叙述 Unlocking the Power of Storytelling in Healthcare Communication In the realm of healthcare communication, persuasion…Certara2024 年 11 月 14 日
PBPK Modeling to Support Bioequivalence & Generic Product Approvals Blog 支持生物等效性和仿制药审批的 PBPK 建模 Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally…Certara2024 年 11 月 12 日
Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting Blog 2024 年 Pinnacle 21 Enterprise 用户会议上聚焦临床研究软件 On 2024 年 10 月 30 日, we hosted our Pinnacle 21 Enterprise (P21E) User Group Meeting (UGM)…Certara2024 年 11 月 12 日
4 Ways to Optimize Agency Partnerships Using a Platform-Oriented Approach Blog 使用平台导向法优化机构合作关系的 4 种方法 In the pharmaceutical and medical devices industries, the journey from product development to market introduction…Certara2024 年 11 月 8 日
Why Clinical Pharmacology & Pharmacometrics Should Collaborate Blog 临床药理学与定量药理学为何要合作 A symbiosis between a modeler and a trialist is often required to develop a model-informed…Certara2024 年 11 月 8 日
FAQs on Developing EMA Policy 0070 Submissions Blog 制定 EMA 政策0070 提交材料的常见问题解答 In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish…Certara2024 年 11 月 1 日
Mathematical Models can Assist in Broadening use of Immuno-oncology Drugs to Treat Autoimmunity Blog 数学模型有助于扩大免疫肿瘤药物治疗自身免疫疾病的应用范围 Connecting Cancer and Autoimmunity "The dosing regimens in oncology may not directly inform the optimal…Certara2024 年 10 月 31 日