The Reference-scaled Average Bioequivalence (RSABE) Approach Blog 参比标度平均生物等效性(Reference-scaled Average Bioequivalence, RSABE)方法 We examine the Reference-scaled Average Bioequivalence (RSABE) approach for generic drug development and how it…Certara2025 年 7 月 1 日
5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address Blog 5 大临床开发挑战 — 基于模型的荟萃分析(MBMA)助力应对 2025 年 6 月 30 日 Drug development is increasingly defined by its complexity. Teams must navigate rising…Certara2025 年 6 月 30 日
Maintain & Adapt Pharma Market Access Digital Tools Using Feedback Blog 通过反馈维护与调整医药市场准入数字工具 Maintain the credibility of your pharma market access digital tools through continuous updates based on…Certara2025 年 6 月 30 日
The Do’s and Don’ts of Define.xml Blog Define.xml 递交的 Do’s 与 Don’ts Discover the 6 dos and don’ts of creating compliant define.xml files for FDA submission with…Certara2025 年 6 月 27 日
FDA ESG NextGen for Regulatory Submissions Blog FDA ESG NextGen 助力监管申报 The FDA ESG NextGen for Regulatory Submissions has replaced the FDA’s WebTrader and simplifies pharmaceutical…Certara2025 年 6 月 25 日
How a budget-impact analysis complements cost-effectiveness to present a balanced economic outlook Blog 互补性评估:预算影响分析与成本效效益分析如何协同构建全面经济模型 2025 年 6 月 16 日 Editor’s note: This is the third of four articles in our series…Simona Colucci2025 年 6 月 16 日
Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance Blog 基于 MIDD 重塑监管策略:《ICH M15 指南草案》深度剖析 With the release of the draft ICH M15 guidance, MIDD is no longer optional -…Certara2025 年 6 月 11 日
常见体外药物相互作用研究缺陷有哪些? 博客 常见体外药物相互作用研究缺陷有哪些? Certara drug interaction science experts share data and experimental design gaps commonly found in in…Certara2025 年 6 月 9 日
Systems modeling helps optimize safety and efficacy for oncolytic viruses Blog 系统建模有助于优化溶瘤病毒的安全性与有效性 2025 年 5 月 30 日 Gene therapies delivered in viral vectors offer an exciting and challenging approach…Certara2025 年 5 月 30 日
‘Most Favored Nation’ Policy Could Have Profound Impact on Global Drug Pricing if Fully Implemented Blog ‘Most Favored Nation’ 政策若全面实施或对全球药品定价产生深远影响 Editor’s Note: Jiwon Oh provided research support for this article. She is a Certara Market…Certara2025 年 5 月 23 日