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 Clesrovimabin 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
