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
Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants
This study, published in Clinical Pharmacology & Therapeutics (CPT), shows how population pharmacokinetic modeling supports…
Certara2026 年 2 月 2 日
Modeling Population PK with Power, Speed, and Ease-of-Use (Phoenix® NLME & Pirana®)
Discover population PK modeling made faster and easier with Phoenix NLME and Pirana in this…
Certara2026 年 1 月 30 日
