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…

Certara2026 年 4 月 10 日

Conference

AMWA NorCal Pacific Coast Conference

Danielle Pillsbury2026 年 4 月 8 日

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…

Certara2026 年 4 月 7 日

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…

Certara2026 年 4 月 6 日

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…

Certara2026 年 4 月 2 日

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 Pillsbury2026 年 4 月 2 日

Press Coverage Video

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

Blog

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

eBook

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

Publication

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…

Certara2026 年 3 月 25 日

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

AMWA NorCal Pacific Coast Conference

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

How Bayesian Design Is Reshaping Clinical Development

Shaping the future of medical writing: Key themes for 2026

The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

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