Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC Blog Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the…Jim Gallagher2025 年 2 月 19 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…Jim Gallagher2024 年 11 月 12 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…Jim Gallagher2024 年 11 月 1 日
AIFA makeover: Italy’s leap into 2024 Blog AIFA 改头换面:意大利飞跃 2024 Explore AIFA’s regulatory transformation.Jim Gallagher2024 年 10 月 4 日
How a top 10 pharma fought the rising tide of non-CRF data Case Study 一家顶级前 10 制药公司如何应对非 CRF 数据日益增长的趋势 Discover how a top pharma company used Pinnacle 21 Data Exchange to automate non-CRF data…Jim Gallagher2024 年 6 月 17 日
Phoenix UGM 2024: A Day of Innovation and Collaboration Blog Phoenix UGM 2024: A Day of Innovation and Collaboration The Phoenix UGM featured industry expert insights, peer networking, and glimpses into the latest PK/PD…Jim Gallagher2024 年 5 月 31 日
CODEX Clinical Outcomes Database Fact Sheet CODEX Clinical Outcomes Database Jim Gallagher2024 年 5 月 30 日
CERTAINTY 2024: The power of Model-Informed Drug Development Blog CERTAINTY 2024: 模型引导的药物开发的强大力量 We cover the key takeaways from CERTAINTY 2024, including the power of Model-Informed Drug Development…Jim Gallagher2024 年 5 月 23 日
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates Blog 对 FDA 新抗体-药物偶联物临床药理指南的思考 In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…Jim Gallagher2024 年 5 月 10 日
Certara Reports First Quarter 2024 Financial Result Press Release Certara 公布 2024 年第一季度财报 Reiterates Full Year 2024 Financial Guidance PRINCETON, N.J.— May 7, 2024-- Certara, Inc. (纳斯达克股票代码:CERT), a…Jim Gallagher2024 年 5 月 7 日