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
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
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…
Certara2026 年 1 月 30 日
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…
Certara2026 年 1 月 30 日
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,…
Certara2026 年 1 月 26 日
