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
Certara IQ™ Global Roadshow
Certara IQ™ is going on the road. From APAC to Europe to North America, our…
CertaraFebruary 12, 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
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
How Model-Informed Drug Development (MIDD) Strengthens Drug Asset Valuation and Answers the Questions Investors Care About Most
Learn how Model-Informed Drug Development strengthens drug asset valuation by reducing uncertainty, predicting clinical performance,…
CertaraJanuary 26, 2026
Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients
This article explores how model-based meta-analysis (MBMA) performs when combining aggregate data and individual patient…
CertaraJanuary 22, 2026
