On Rare Disease Day 2026, Certara experts share how cross-functional innovation, regulatory strategies for rare…
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
Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)
Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…
Certara2026 年 2 月 13 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
Why Many Global Drugs Never Reach Japan
Despite faster reviews, many global drugs never reach Japan. Learn how early development decisions, trial…
Certara2026 年 2 月 5 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…
Certara2026 年 2 月 3 日
