Beyond Trial and Error: Model-Informed Formulation Development in Practice
Siri Kalyan Chirumamilla2026 年 8 月 24 日
Tailwinds for MIDD: What to Know About the Changing Regulatory Landscape
2026 年 9 月 30 日 - 11:30 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
