Upcoming Webinars:
Featured Webinars:
MembranePlus™ v2 webinar: Stimulate your kinetic understanding…
Use of oral absorption modelling to characterize drug release and absorption of a BCS II compound from IR formulations
Watch Past Webinars
NAFLDsym v2A Release Webinar
NAFLDsym v2A includes mechanistic representation of fibrosis, steatosis, lipotoxicity, and inflammation. Over 1000 simulated patients with variability in their underlying pathophysiology, represent a spectrum of fibrotic disease (F0-F4 stages). Multiple biomarkers (e.g., MRE, MRI, ALT, NAS, Pro-C3) for patient stratification and evaluation of efficacy are included.
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DDDPlus v6: In Vitro Dissolution… Reimagined
In vitro-in vivo extrapolation (IVIVE) has been a major focus of biopharmaceutics research over the last 20 years, and integration of in silico models built in GastroPlus™ help researchers identify in vitro methods for dissolution and precipitation that are more predictive. DDDPlus™ 6.0 is our updated in vitro platform that provides new functionality and models to evaluate precipitation kinetics of formulations.
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Applying GastroPlus Modeling Establish Level A IVIVCs Waive Biostudies
Bioavailability/bioequivalence (BA/BE) evaluation by employing in vitro dissolution/release data and clinically relevant specification is required by the regulators. For BCS 1/BCS 3 drugs formulated as immediate release (IR) oral dosage forms, a BCS-based biowaiver may be granted based on the in vitro dissolution profiles generated across the physiologically relevant pH range. For drugs/formulations with dissolution/release limited/controlled absorption, establishing Level A in vitro – in vivo correlations (IVIVCs) can be applied and further utilized to assess whether BA/BE is recommended.
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Applying MAM/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations
It is widely recognized that food can affect the absorption of orally administered drugs. In the course of pharmaceutical development, food is evaluated clinically as part of the early single or multiple ascending dose studies; additional evaluations often take place when there are formulation changes. The outcome of these studies informs dosing instructions both during the conduct of clinical trials as well as on the product label.
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GastroPlus™ 9.6 Release Webinar: Improvements Supporting R&D Through Regulatory Interactions
We are pleased to announce the release of GastroPlus™ 9.6! These improvements in our top-ranked PBPK modeling platform support discovery/preclinical/clinical R&D work through regulatory interactions.
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