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
CertaraJuly 1, 2026
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,…
CertaraJuly 1, 2026
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…
CertaraJune 26, 2026
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…
CertaraJune 26, 2026
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…
CertaraJune 26, 2026
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…
CertaraJune 26, 2026
PBPK Modelling of Bispecific Monoclonal Antibody Tumour Targeting Specificity
Explore how PBPK modelling evaluates the in vivo tumour-targeting specificity of bispecific monoclonal antibodies (bsmAbs),…
CertaraJune 25, 2026
Sex-Specific Bioequivalence Outcomes: PBPK Insights into Gastric Emptying Variability
Discover how sex-dependent within-subject variability in gastric emptying time influences supersaturation, precipitation, and Cmax in…
CertaraJune 25, 2026
PBPK Modelling of Formulation-Dependent Food Effects for Itraconazole Oral Solution
Explore mechanistic PBPK modelling of itraconazole oral solution, revealing how bile salt–cyclodextrin interactions drive a…
CertaraJune 25, 2026
