From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs
New CPT review by Certara's Karen Rowland Yeo & Piet van der Graaf shows how…
Danielle Pillsbury2026 年 9 月 23 日
Model-Informed Strategies for ADC Development
Explore how model informed drug development can help ADC developers optimize dosing, reduce uncertainty, strengthen…
Danielle Pillsbury2026 年 9 月 22 日
Semi-Mechanistic Joint Population Pharmacokinetic Modeling of the Novel Antituberculosis Drug Sorfequiline and Its Metabolite M3 in Healthy Volunteers
A semi-mechanistic population PK model characterizes sorfequiline and its active M3 metabolite to support DDI…
Certara2026 年 9 月 18 日
Pharmacometric Analysis of Givinostat to Support Individualized Dosing Recommendations in Pediatric Patients with Duchenne Muscular Dystrophy
Pharmacometric modeling of givinostat in pediatric DMD supported a simplified 4-band weight-based dosing regimen without…
Certara2026 年 9 月 14 日
Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in drug development
A new paper argues context of use, not NAMs-versus-animals, should govern nonclinical strategy in drug…
Danielle Pillsbury2026 年 9 月 9 日
From Models to Decisions: Building MIDD Readiness in the Era of ICH M15
Explore what ICH M15 means for Model-Informed Drug Development and learn how to build MIDD…
Rik de Greef2026 年 9 月 9 日
A glimpse into the future of model-informed drug discovery and development
Explore the future of Model-Informed Drug Development (MIDD), including advances in pharmacometrics, PBPK, QSP, precision…
Certara2026 年 8 月 28 日
Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology
Explore how model-based tumor growth inhibition metrics can support earlier Go/No-Go decisions and pivotal trial…
Certara2026 年 8 月 28 日
