Drug Development Archives

On-Demand Webinar

Compliance? Anywhere, anytime: Automated controlled substance detection and tariff classification at Merck KGaA

Learn how Merck KGaA automates controlled substance detection and HS classification to ensure global compliance…

CertaraApril 27, 2026

Conference

ACS Fall 2026

– – Booth

CertaraApril 27, 2026

Fact Sheet

DIDB® Concomitant Meds Navigator

Explore the Concomitant Meds Navigator withing DIDB - An evidence-based tool within DIDB that helps…

CertaraApril 27, 2026

Blog

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

On-Demand Webinar

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

Case Study

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

On-Demand Webinar

Earning Regulatory Trust: Practical Strategies to Increase Model Acceptance in MIDD

Discover practical strategies to increase regulatory trust and acceptance of MIDD models, including PBPK and…

CertaraApril 6, 2026

On-Demand Webinar

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

Publication

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

Infographic

6 ways Pinnacle 21 Enterprise centralized validation across studies

Learn how to centralize clinical data validation across studies using Pinnacle 21 Enterprise to improve…

CertaraApril 1, 2026

Drug Development

Compliance? Anywhere, anytime: Automated controlled substance detection and tariff classification at Merck KGaA

ACS Fall 2026

DIDB® Concomitant Meds Navigator

ADC Dose Optimization: Applying Model-Informed Strategies in Development

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

Earning Regulatory Trust: Practical Strategies to Increase Model Acceptance in MIDD

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

6 ways Pinnacle 21 Enterprise centralized validation across studies

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