GxP Compliance in the Cloud: What IT Teams Need to Rethink
Learn how GxP validation works in modern SaaS and cloud environments, with best practices for…
Certara2026 年 5 月 4 日
Allometric Approach in pharmacokinetics when and how to use it
Danielle Pillsbury2026 年 4 月 28 日
ADC Dose Optimization: Applying Model-Informed Strategies in Development
Explore ADC dose optimization using model-informed strategies to balance efficacy and safety across antibody drug…
Certara2026 年 4 月 22 日
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
PK Parameters Explained: From Cmax to Clearance (and Why It Matters for Development Decisions)
Learn how key PK parameters such as Cmax, AUC, clearance, half life, and volume of…
Certara2026 年 4 月 9 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
Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations
Watch this on-demand webinar to learn how the final ICH M15 guidance is shaping Model-Informed…
Certara2026 年 4 月 2 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
Integrated PK/PD Modeling and Machine Learning to Support CNS Compound Selection
PK/PD Modeling for CNS drug development using Phoenix NLME and machine learning for better CNS…
Certara2026 年 3 月 26 日
