The Reference-scaled Average Bioequivalence (RSABE) Approach
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
2025 年 6 月 30 日 Drug development is increasingly defined by its complexity. Teams must navigate rising…
Certara2025 年 6 月 30 日
How Model-informed drug development rescue projects from a risky situation
Discover how Certara’s integrated approach to model-informed drug development helps clients navigate regulatory challenges, achieve…
Certara2025 年 6 月 26 日
Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer
The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…
Certara2025 年 6 月 8 日
Extrapolating AUC to Infinity
AUC 计算简单，但也有细微差别。In this blog, we look at how to extrapolate…
Certara2025 年 5 月 15 日
