Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development Blog 为什么 FDA 关于循环肿瘤 DNA 的新指南对肿瘤早期临床药物开发至关重要 2022 is shaping up to be the “year of the guidance” as the FDA has…Certara2022 年 7 月 1 日
Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline Blog Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public…Certara2022 年 6 月 14 日
The Utility of Model-Informed Drug Development for Rare Diseases Blog 罕见病药物开发模型的实用性 Model-informed drug development (MIDD) is a network of closely integrated ecosystems that can seamlessly position…Certara2022 年 5 月 20 日
5 Reasons Why You Should Use Phoenix WinNonlin for PK/PD Analyses Blog Phoenix WinNonlin 助力 PK/PD 分析的 5 大核心优势 Pharmaceutical companies around the globe face the challenge of increasingly longer drug development cycles and…Certara2022 年 3 月 25 日
How to Fix Your Biggest Bioequivalence Mistakes Blog 如何纠正生物等效性评估中的重大误区 生物等效性是生物药剂学中普遍被误解的术语。For starters, bioequivalence is a technical term…Certara2022 年 3 月 16 日
New PMDA Validation Rules 3.0 Explained Blog New PMDA Validation Rules 3.0 Explained In this blog, we explore what you need to know about the update to the…Certara2022 年 3 月 2 日
Experts Unravel the Top 5 Myths Related to Bioequivalence Blog 专家解读生物等效性 5 大误区 生物等效性通过药代动力学桥接口服药物剂型的安全性与有效性,The concepts…Certara2022 年 2 月 18 日
什么是 FDA Project Optimus?它会如何影响肿瘤药物开发? 博客 什么是 FDA Project Optimus?它会如何影响肿瘤药物开发? Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…Certara2022 年 2 月 2 日
Choosing an eCTD Submissions Vendor: Your Complete Checklist Blog Choosing an eCTD Submissions Vendor: Your Complete Checklist Selecting the right electronic submission services vendor for your organization’s regulatory submissions to health authorities…Certara2022 年 1 月 28 日
Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development Blog 不要忘记安全!如何在早期临床开发中评估候选药物的安全性 This blog will reflect on 3 things drug developers should pay attention to regarding safety…Certara2022 年 1 月 24 日