Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations Webinar Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations Danielle PillsburyApril 2, 2026
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 PillsburyApril 2, 2026
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…CertaraMarch 27, 2026
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 2026CertaraMarch 26, 2026
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…CertaraMarch 26, 2026
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…CertaraMarch 25, 2026
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…CertaraMarch 25, 2026
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…CertaraMarch 24, 2026
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 PillsburyMarch 24, 2026
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…CertaraMarch 19, 2026