Journal: Pharmaceutical Research

Article Title: PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations

doi: 10.1007/s11095-025-03846-y

Figure Lengend Snippet: Absorption simulations based on four mechanistic oral absorption (MOA) models.

Article Snippet: The presentation explored the assumptions in the passive permeation of drugs across the GI membrane within the framework of four MOA models: GastroPlus Advanced Compartmental Absorption and Transit (ACAT) model, Simcyp Advanced Dissolution, Absorption, and Metabolism (ADAM) model with standard Peff, Simcyp ADAM model with Mech-Peff, and Simcyp Multi-layer gut wall within ADAM (M-ADAM) model.

Techniques:

Journal: Pharmaceutics

Article Title: Advanced In Vivo Prediction by Introducing Biphasic Dissolution Data into PBPK Models

doi: 10.3390/pharmaceutics15071978

Figure Lengend Snippet: Simulated plasma concentration time profile using GastroPlus ® (blue line) and observed pharmacokinetic data (red dots): ( A ) aprepitant after a 2 h infusion, ( B ) celecoxib following an oral solution, ( C ) fenofibrate administered as oral solution, ( D ) nimodipine administered by a single injection, ( E ) itraconazole after infusion of a cyclodextrin-based formulation, ( F ) itraconazole after oral administration of a solution formulation, and ( G ) ritonavir administered as oral solution.

Article Snippet: PBPK modelling was performed using GastroPlus ® 9.6 (Simulations Plus, Inc., Lancaster, CA, USA) and PK-Sim 7.3, which is part of the Open Systems Pharmacology Suite (Bayer Technology, Bayer AG, Leverkusen, Germany).

Techniques: Clinical Proteomics, Concentration Assay, Injection, Formulation

Journal: Pharmaceutics

Article Title: Advanced In Vivo Prediction by Introducing Biphasic Dissolution Data into PBPK Models

doi: 10.3390/pharmaceutics15071978

Figure Lengend Snippet: Simulated plasma concentration time profile based on in vitro distribution data of the BiPHa+ dissolution test using the GastroPlus ® controlled release function after oral administration (blue line) and in vivo data (red dots) for the drug products of ( A ) aprepitant, ( B ) celecoxib, ( C ) schfenofibrate, ( D ) nimodipine, ( E ) itraconazole, and ( F ) ritonavir.

Article Snippet: PBPK modelling was performed using GastroPlus ® 9.6 (Simulations Plus, Inc., Lancaster, CA, USA) and PK-Sim 7.3, which is part of the Open Systems Pharmacology Suite (Bayer Technology, Bayer AG, Leverkusen, Germany).

Techniques: Clinical Proteomics, Concentration Assay, In Vitro, Dissolution, In Vivo

Journal: Pharmaceutics

Article Title: Advanced In Vivo Prediction by Introducing Biphasic Dissolution Data into PBPK Models

doi: 10.3390/pharmaceutics15071978

Figure Lengend Snippet: Verification of enabling formulation PBPK in GastroPlus ® or PK-Sim and PK models including the biphasic dissolution profiles by comparing observed vs. predicted values: ( A ) AUC values and ( B ) C max values. The dark grey line represents the line of identical observed in vivo and predicted. The light grey solid lines represent the 2-fold, the light grey dotted lines the 1.25-fold boundary.

Article Snippet: PBPK modelling was performed using GastroPlus ® 9.6 (Simulations Plus, Inc., Lancaster, CA, USA) and PK-Sim 7.3, which is part of the Open Systems Pharmacology Suite (Bayer Technology, Bayer AG, Leverkusen, Germany).

Techniques: Formulation, Dissolution, In Vivo