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…
CertaraMay 4, 2026
Allometric Approach in pharmacokinetics when and how to use it
Danielle PillsburyApril 28, 2026
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…
CertaraApril 22, 2026
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…
CertaraApril 10, 2026
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…
CertaraApril 9, 2026
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…
CertaraApril 7, 2026
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…
CertaraApril 2, 2026
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 PillsburyApril 2, 2026
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…
CertaraMarch 26, 2026
