Upcoming Webinars:
Using Quantitative Systems Toxicology (QST): Improving the safety of drugs while reducing animal testing
July 24, 2019
7:00 – 8:00 AM PDT
Register Here!
Featured Webinars:
GastroPlus® v9.7 Release Webinar
Molecular Determinants of Cell Permeability Beyond the Rule of 5
Watch Past Webinars
GastroPlus® User Group Webinar: Applications/Experiences of PBPK Modeling to Support Regulatory Interactions
Recent experiences with PBPK model-based regulatory submissions used to obtain product development and DDI waivers will be discussed.
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Physiology Based Pharmacokinetic Modeling in Generic Drug Development and Regulatory Decisions- Opportunities & Challenges
Physiology based pharmacokinetic (PBPK) modeling is widely used within the pharmaceutical industry to predict oral drug absorption.
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GastroPlus® v9.7 Release Webinar
Learn about the latest developments in GastroPlus®!
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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...
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ADMET Predictor® 9.5 Webinar
Significant enhancements have been made throughout both ADMET Predictor and MedChem Designer™.
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DILIsym® v8A Release Webinar
DILIsym is a mechanistic, predictive software tool focused on predicting and understand drug-induced liver injury across species. DILIsym version 8A is packed with exciting new features.
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Molecular Determinants of Cell Permeability Beyond the Rule of 5
Molecules that violate conventional guidelines for druglikeness—such as the Rule-of-5—are of increasing interest as chemical probes and drugs for intractable pharmacological targets.
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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...
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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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