Assessing Cross-Version Simcyp Simulator Prediction Performance Using a Bioequivalence Framework to Support EMA Qualification Poster 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 Blog 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,…Certara2026 年 7 月 13 日
Integrated mechanistic modeling approaches in oncology drug development Webinar Integrated mechanistic modeling approaches in oncology drug development Certara2026 年 7 月 8 日
PBPK Modeling in Lieu of Clinical Endpoint Bioequivalence Study for Generic Tazarotene Cream 0.05% Poster 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 productCertara2026 年 7 月 1 日
The Power of Modeling: Speed, Early De-Risking, and Regulatory Success for Forward-Thinking Sponsors On-Demand Webinar 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 Poster 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 Poster 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 Poster 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 Poster 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
PBPK Modelling of Bispecific Monoclonal Antibody Tumour Targeting Specificity Poster 双特异性单克隆抗体肿瘤靶向特异性的 PBPK 建模 Explore how PBPK modelling evaluates the in vivo tumour-targeting specificity of bispecific monoclonal antibodies (bsmAbs),…Certara2026 年 6 月 25 日