How Do You Know You Have the Right Dose? Using Exposure-Response Evidence to Justify and Defend Dose Decisions Webinar How Do You Know You Have the Right Dose? Using Exposure-Response Evidence to Justify and Defend Dose Decisions Danielle PillsburyOctober 1, 2026
Get the Presentation: Building Investor-Ready Biotech Strategies Guide Get the Presentation: Building Investor-Ready Biotech Strategies Get the full presentation from Certara's Biotech Forum on building investor-ready development strategies ahead of…Diana Marcantonio, PhDSeptember 29, 2026
Model-Informed Strategies for ADC Development White Paper Model-Informed Strategies for ADC Development Explore how model informed drug development can help ADC developers optimize dosing, reduce uncertainty, strengthen…Danielle PillsburySeptember 22, 2026
When EV Dose Is Not What It Seems: Quantitative Mismatch Between Particle Number- and Protein-Based Dosing Publication When EV Dose Is Not What It Seems: Quantitative Mismatch Between Particle Number- and Protein-Based Dosing Research shows that particle- and protein-based extracellular vesicle dosing are not interchangeable, supporting a multidimensional…CertaraSeptember 18, 2026
Semi-Mechanistic Joint Population Pharmacokinetic Modeling of the Novel Antituberculosis Drug Sorfequiline and Its Metabolite M3 in Healthy Volunteers Publication 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…CertaraSeptember 18, 2026
Pharmacometric Analysis of Givinostat to Support Individualized Dosing Recommendations in Pediatric Patients with Duchenne Muscular Dystrophy Poster 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…CertaraSeptember 14, 2026
Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in drug development Publication 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 PillsburySeptember 9, 2026
From Models to Decisions: Building MIDD Readiness in the Era of ICH M15 Guide From Models to Decisions: Building MIDD Readiness in the Era of ICH M15 Build the governance, capabilities, and cross-functional alignment that turn MIDD evidence into decision-ready evidence under…Rik de GreefSeptember 9, 2026
A Best Practice Guide to Validation in Clinical Data Management Guide A Best Practice Guide to Validation in Clinical Data Management Learn best practices for software validation in research settings with this guide to validation in…Danielle PillsburySeptember 2, 2026
A glimpse into the future of model-informed drug discovery and development Publication 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…CertaraAugust 28, 2026