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
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
Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach
Explore how a collaborative “sandbox” approach—combining flexible regulation, data modeling, and stakeholder engagement—can transform rare…
CertaraJanuary 30, 2026
P21 Enterprise Expands Regulatory Validation Capabilities with Support for the Tobacco Implementation Guide v1.0
Pinnacle 21 supports TIG v1.0, the CDISC Tobacco Implementation Guide for FDA CTP, enabling automated…
CertaraJanuary 30, 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
