Tailwinds for MIDD: What to Know About the Changing Regulatory Landscape
2026年6月30日 - 12:00 PM – 2:00 PM
Certara2026年8月12日
Assessing Cross-Version Simcyp Simulator Prediction Performance Using a Bioequivalence Framework to Support EMA Qualification
See how Simcyp Simulator V20–V24 DDI predictions were shown equivalent to the EMA-qualified V19 using…
Certara2026年7月24日
When to conduct hepatic impairment studies and when modeling may be enough
How to decide if a hepatic impairment study is required, choose the right study design,…
Zoe Barter2026年7月13日
PBPK Modeling in Lieu of Clinical Endpoint Bioequivalence Study for Generic Tazarotene Cream 0.05%
Learn how Simcyp PBPK modeling established bioequivalence and supported FDA approval of a generic product
Certara2026年7月1日
The Power of Modeling: Speed, Early De-Risking, and Regulatory Success for Forward-Thinking Sponsors
The Power of Modeling: Speed, Early De-Risking, and Regulatory Success for Forward-Thinking Sponsors
Learn how PBPK and QSP modeling support faster drug development by enabling smarter dose selection,…
Certara2026年7月1日
Mechanistic Surface pH Modelling Improves PBPK Prediction of a Weakly Acidic Drug: Case Study of Bempedoic Acid
Explore how mechanistic surface pH modeling in Simcyp improves PBPK prediction of dissolution-controlled absorption for…
Certara2026年6月26日
Dermal PBPK Modelling of Propylparaben with a Novel Skin Metabolism Framework
Explore how a mechanistic dermal PBPK model with experimentally scaled, layer-specific skin metabolism predicts propylparaben…
Certara2026年6月26日
Application of PBPK Modelling to Explore Complex Food Effects on Trospium Chloride Pharmacokinetics
Discover how PBPK modeling with Simcyp mechanistically explains the formulation-dependent negative food effect of trospium…
Certara2026年6月26日
Cross-Version Simcyp Simulator Performance Assessment Using a Bioequivalence Framework for EMA Qualification
Learn how Certara used a bioequivalence-based TOST framework to demonstrate that Simcyp Simulator versions V20–V24…
Certara2026年6月26日
