Model Informed Drug Development Archives

Publication

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Population pharmacokinetic (PopPK) and exposure-response modeling were used to support the clinical development of nemtabrutinib,…

Certara2026 年 5 月 7 日

Blog

Top 10 Benefits of Simcyp® Simulator for Drug Development

JTVCdGVhbV9qdW1wX2xpc3QlNUQ= 2026 年 4 月 23 日 Physiologically based pharmacokinetic (PBPK) modeling has evolved from an emerging methodology…

Certara2026 年 4 月 23 日

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…

Certara2026 年 4 月 22 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

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

Publication

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

This review article examines the development of radiopharmaceutical imaging agents and radioligand therapies for pediatric…

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

On-Demand Webinar

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Watch this on-demand webinar to learn how model-informed strategies using PopPK, PBPK, and QSP can…

Certara2026 年 3 月 25 日

Blog

Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3

Learn how advanced modeling for reimbursement strategy using MBMA and QSP strengthens payer evidence and…

Certara2026 年 3 月 24 日

模型引导的药物开发

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Top 10 Benefits of Simcyp® Simulator for Drug Development

ADC Dose Optimization: Applying Model-Informed Strategies in Development

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

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

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

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

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3

订阅时事通讯

快捷链接

解决方案

联系我们