Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations Webinar Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations Danielle Pillsbury2026 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 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
How Bayesian Design Is Reshaping Clinical Development Press CoverageVideo 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
Shaping the Future of Medical Writing: Key Themes for 2026 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 2026Certara2026 年 3 月 26 日
The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration 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
An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors 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
Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs) 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
Building Smarter Trials With Bayesian Statistics Press CoverageVideo Building Smarter Trials With Bayesian Statistics Learn how Bayesian statistics are transforming clinical trials with adaptive designs, faster insights, and more…Certara2026 年 3 月 24 日
Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis Publication Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis This study evaluated the pharmacokinetics (PK) and pharmacokinetic–pharmacodynamic (PK–PD) relationship of clazakizumab, an anti–interleukin-6 (IL-6)…Danielle Pillsbury2026 年 3 月 24 日
Pediatric Drug Development and Pharmacometrics: Key Questions Sponsors Must Answer Guide Pediatric Drug Development and Pharmacometrics: Key Questions Sponsors Must Answer Download Certara’s expert guide on pharmacometrics and pediatric drug development. Learn how modeling, MIDD, and…Certara2026 年 3 月 19 日