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…
CertaraFebruary 18, 2026
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…
CertaraFebruary 13, 2026
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…
CertaraFebruary 11, 2026
Why Many Global Drugs Never Reach Japan
Despite faster reviews, many global drugs never reach Japan. Learn how early development decisions, trial…
CertaraFebruary 5, 2026
Trial Designs: Non-inferiority vs. Superiority vs. Equivalence
Understand superiority, non-inferiority, and equivalence trials, how their hypotheses differ, and how trial design impacts…
CertaraFebruary 3, 2026
Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants
This study, published in Clinical Pharmacology & Therapeutics (CPT), shows how population pharmacokinetic modeling supports…
CertaraFebruary 2, 2026
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…
CertaraJanuary 30, 2026
Regulatory-Trusted Software for Smarter PK/PD Workflows (Phoenix WinNonlin®)
This on demand session demonstrates how Phoenix WinNonlin® and other tools work together within Phoenix®…
CertaraJanuary 27, 2026
