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FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development Blog 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
Pediatric Drug Development: From “Wild West” to Model-Informed Confidence Blog 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
QSP in Inflammatory Bowel Disease (IBD): From Biomarkers to Clinical Endpoints, with Virtual Patients Blog QSP in Inflammatory Bowel Disease (IBD): From Biomarkers to Clinical Endpoints, with Virtual Patients Certara supports IBD drug development with a QSP model that predicts Mayo score and CDAI…CertaraFebruary 10, 2026
Trial Designs: Non-inferiority vs. Superiority vs. Equivalence BlogKnowledge Base 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
How Quantitative Systems Pharmacology Addresses Key Challenges in Alzheimer’s Drug Development Blog How Quantitative Systems Pharmacology Addresses Key Challenges in Alzheimer’s Drug Development Quantitative Systems Pharmacology (QSP) helps address key challenges in Alzheimer’s disease drug development, including tau…CertaraFebruary 2, 2026
P21 Enterprise Expands Regulatory Validation Capabilities with Support for the Tobacco Implementation Guide v1.0 Blog 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
Certainty Discovery. Frankfurt, November 4-5, 2025 Blog Certainty Discovery. Frankfurt, November 4-5, 2025 Certainty Discovery 2025 review by Wendy A. Warr - Vibes, topics and key takeaways.CertaraJanuary 29, 2026