Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer
This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…
Danielle Pillsbury2026 年 3 月 4 日
ADC first-in-human (FIH) dose selection: Designing FIH studies for success
Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…
Certara2026 年 3 月 3 日
On Rare Disease Day 2026, Certara experts share how cross-functional innovation, regulatory strategies for rare…
Certara2026 年 2 月 26 日
From documentation to design: Building a scalable metadata strategy for clinical research
Learn how clinical teams are treating metadata as infrastructure to improve reuse, auditability, and standards…
Certara2026 年 2 月 26 日
Metatdata as Infrastructure: Designing for Reuse, Insight, and Auditability
Watch this on-demand webinar to learn how leading clinical teams design scalable metadata strategies that…
Certara2026 年 2 月 26 日
Start right, finish strong: Antibody-drug conjugate (ADC) studies for success
Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how…
Certara2026 年 2 月 23 日
FAQs: The ICH M15 guideline and what it means for model-informed drug development
Learn what the ICH M15 guideline means for Model-Informed Drug Development, regulatory credibility, harmonization, and…
Certara2026 年 2 月 18 日
Pediatric drug development: From “wild west” to model-informed confidence
Model-informed drug development and precision dosing are transforming pediatric programs, from regulatory planning to Bayesian…
Certara2026 年 2 月 11 日
Trial designs: Non-inferiority vs. superiority vs. equivalence
Understand superiority, non-inferiority, and equivalence trials, how their hypotheses differ, and how trial design impacts…
Matt Zierhut, PhD MBA2026 年 2 月 3 日
