Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access
Learn how model-informed strategies support ADC labeling, dose optimization, and market access through integrated evidence…
Certara2026 年 4 月 10 日
How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer
HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…
Certara2026 年 4 月 7 日
Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib
This study demonstrates how a model-informed, totality-of-evidence approach was used to select the optimal clinical…
Danielle Pillsbury2026 年 4 月 2 日
How Bayesian Design Is Reshaping Clinical Development
Learn how Bayesian design is reshaping clinical trials with adaptive methods that improve efficiency, reduce…
Certara2026 年 3 月 27 日
Shaping the Future of Medical Writing: Key Themes for 2026
Five key themes and their implications for leaders shaping their Medical Writing strategy for 2026
Certara2026 年 3 月 26 日
The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration
Discover advanced regulatory writing strategies, global regulatory submission best practices, eCTD guidance, ICH M15 updates…
Certara2026 年 3 月 26 日
