MIDD can ease pediatric & rare disease drug loss in Japan
Certara tackles pediatric cancer and rare disease drug loss in Japan by advocating MIDD, which…
Certara2025 年 7 月 8 日
Accelerating Oncology Drug FDA Submission with Project Management Services
Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…
Certara2025 年 7 月 2 日
The Medicine Maker: The Biosimulation Generation
The article, The Biosimulation Generation, explores the transformative potential of biosimulation in pharmaceutical R&D as…
Danielle Pillsbury2025 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
Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning
Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…
Danielle Pillsbury2025 年 6 月 19 日
Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance
With the release of the draft ICH M15 guidance, MIDD is no longer optional -…
Certara2025 年 6 月 11 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
