How Bayesian Design Is Reshaping Clinical Development
Learn how Bayesian design is reshaping clinical trials with adaptive methods that improve efficiency, reduce…
CertaraMarch 27, 2026
Where Did the 80-125% Bioequivalence Criteria Come From?
Discover what bioequivalence criteria mean, why the 80-125% bioequivalence range is used, and how custom…
CertaraMarch 27, 2026
Integrated PK/PD Modeling and Machine Learning to Support CNS Compound Selection
PK/PD Modeling for CNS drug development using Phoenix NLME and machine learning for better CNS…
CertaraMarch 26, 2026
Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics
This review article examines the development of radiopharmaceutical imaging agents and radioligand therapies for pediatric…
CertaraMarch 26, 2026
Shaping the Future of Medical Writing: Key Themes for 2026
Five key themes and their implications for leaders shaping their Medical Writing strategy for 2026
CertaraMarch 26, 2026
The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration
Discover advanced regulatory writing strategies, global regulatory submission best practices, eCTD guidance, ICH M15 updates…
CertaraMarch 26, 2026
Portfolio Prioritization for Large and Small Pharma Using Early-Stage Biosimulation
Learn how early-stage biosimulation and mechanistic modeling enable smarter portfolio prioritization before IND-enabling studies. Watch…
CertaraMarch 25, 2026
An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors
This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…
CertaraMarch 25, 2026
Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination
This study showcases how quantitative systems pharmacology (QSP) and model-informed drug development (MIDD) can transform…
Danielle PillsburyMarch 25, 2026
