GastroPlus® User Group Webinar: Physiologically Based Pharmacokinetic Modelling for First‑In‑Human Predictions

GastroPlus® User Group Webinar: Physiologically Based Pharmacokinetic Modelling for First‑In‑Human Predictions

Software: GastroPlus®
Division: Simulations Plus

This webinar provides an overview of a recent publication on physiologically based pharmacokinetic (PBPK) modeling in first in human (FIH) predictions, and this was a collaborative effort from GastroPlus® User Group members.

A practical approach to modeling the impact of amorphous drug nanoparticles on the oral absorption of poorly soluble drugs

A practical approach to modeling the impact of amorphous drug nanoparticles on the oral absorption of poorly soluble drugs

Authors: Stewart AM, Grass M
Publication: Mol Pharm
Software: GastroPlus®

Recently published studies have proposed that amorphous drug nanoparticles in gastrointestinal fluids may be beneficial for the absorption of poorly soluble compounds.

Duration of pretomanid/moxifloxacin/pyrazinamide therapy compared with standard therapy based on time-to-extinction mathematics

Duration of pretomanid/moxifloxacin/pyrazinamide therapy compared with standard therapy based on time-to-extinction mathematics

Publication: J Antimicrob Chemother
Division: Cognigen

Animal models have suggested that the combination of pretomanid with pyrazinamide and moxifloxacin (PaMZ) may shorten TB therapy duration to 3–4 months.

Mechanistic Modelling of the Linkage Between Proximal Tubule Cell Sublethal Injury and Tubular Sodium Reabsorption Impairment

Mechanistic Modelling of the Linkage Between Proximal Tubule Cell Sublethal Injury and Tubular Sodium Reabsorption Impairment

Conference: American Society of Nephrology (ASN)
Software: RENAsym®
Division: DILIsym Services

Sublethal renal epithelial cell injury, a key manifestation of drug-induced acute kidney injury (AKI), is characterized by loss of brush border and cellular polarity of proximal tubular cells (PTCs).

Evaluating the Nephrotoxicity of Exemplar Compounds Using a Mechanistic Model of Drug-Induced Acute Kidney Injury

Evaluating the Nephrotoxicity of Exemplar Compounds Using a Mechanistic Model of Drug-Induced Acute Kidney Injury

Conference: American Society of Nephrology (ASN)
Software: RENAsym®
Division: DILIsym Services

Drug-induced nephrotoxicity is a common source of acute kidney injury (AKI) and a condition that complicates clinical outcomes of vulnerable patients.

Mechanistic Modeling Aids in the Interpretation of Alanine Aminotransferase Elevations Associated with Clinical Ischemic Liver Injury

Mechanistic Modeling Aids in the Interpretation of Alanine Aminotransferase Elevations Associated with Clinical Ischemic Liver Injury

Conference: AASLD
Software: DILIsym®
Division: DILIsym Services

DILIsym® software can use serial serum alanine aminotransferase (ALT) assessments to predict hepatocyte loss (HL) and corresponding changes in total bilirubin (TBIL) due to...

Physiologically Based Pharmacokinetic Model for Voriconazole and Prediction of its Interactions with Midazolam and Alfentanil

Physiologically Based Pharmacokinetic Model for Voriconazole and Prediction of its Interactions with Midazolam and Alfentanil

Conference: AAPS
Software: GastroPlus®
Division: Simulations Plus

Voriconazole (formerly known as UK-109,496), is a second-generation triazole antifungal agent widely used in the treatment of invasive fungal infections.

Exploring Clinical Relevance of Dissolution Testing by Physiologically Based Biopharmaceutics Modeling (PBBM)

Exploring Clinical Relevance of Dissolution Testing by Physiologically Based Biopharmaceutics Modeling (PBBM)

Authors: Novakovic J
Conference: AAPS
Software: GastroPlus®
Division: Simulations Plus

In vitro dissolution testing, if reflective of in vivo drug release/absorption, is considered a surrogate for in vivo drug performance.

Development of Drugs to Treat NAFLD/NASH using Quantitative Systems Pharmacology Modeling

Development of Drugs to Treat NAFLD/NASH using Quantitative Systems Pharmacology Modeling

Authors: Yang K
Conference: AAPS
Software: NAFLDsym®
Division: DILIsym Services

This session will provide scientific background and overview of the application of quantitative systems pharmacology (QSP) modeling in drug development to treat NALFD/NASH