Cosmetics Europe Evaluation of 6 in silico Skin Penetration Models

Cosmetics Europe Evaluation of 6 in silico Skin Penetration Models

Conference: SOT
Software: GastroPlus®

The Cosmetics Europe (CosEche) ADME Task Force aims to evaluate and develop in silico skin penetration models using relevant measured values.

Mechanistic Modeling Of Mitochondrial Biogenesis Within Dilisym Could Explain Clinically Observed Adaptation Of Serum Alanine Aminotransferase Elevations

Mechanistic Modeling Of Mitochondrial Biogenesis Within Dilisym Could Explain Clinically Observed Adaptation Of Serum Alanine Aminotransferase Elevations

Conference: SOT
Software: DILIsym®

Resolution of serum ALT elevations despite continued drug dosing, termed “adaptation”, is commonly observed in clinical trials, but the underlying mechanisms behind this phenomenon remain unclear.

Absolute Oral Bioavailability of Creatine Monohydrate in Rats: Debunking a Myth

Absolute Oral Bioavailability of Creatine Monohydrate in Rats: Debunking a Myth

Publication: Pharmaceutics
Software: GastroPlus®

Creatine is an ergogenic compound used by athletes to enhance performance. Supplementation with creatine monohydrate (CM) has been suggested for musculoskeletal and neurological disorders.

Process optimization and in vivo performance of docetaxel loaded PHBV-TPGS therapeutic vesicles: A synergistic approach.

Process optimization and in vivo performance of docetaxel loaded PHBV-TPGS therapeutic vesicles: A synergistic approach.

Publication: Int J Biol Macromol
Software: GastroPlus®

This research was motivated due to substantial requirement of improved treatment for breast cancer which accounts for over 0.52 million deaths annually worldwide.

Clinical Bioavailability of the Novel BACE1 Inhibitor Lanabecestat (AZD3293): Assessment of Tablet Formulations Versus an Oral Solution and the Impact of Gastric pH on Pharmacokinetics.

Clinical Bioavailability of the Novel BACE1 Inhibitor Lanabecestat (AZD3293): Assessment of Tablet Formulations Versus an Oral Solution and the Impact of Gastric pH on Pharmacokinetics.

Publication: Clin Pharmacol Drug Dev
Software: GastroPlus®
Division: PBPK

The relative bioavailability of lanabecestat administered as 2 tablet formulations versus an oral solution was investigated.

In vitro to in vivo extrapolation for high throughput prioritization and decision making

In vitro to in vivo extrapolation for high throughput prioritization and decision making

Publication: Toxicol In Vitro
Software: GastroPlus®
Division: PBPK

In vitro chemical safety testing methods offer the potential for efficient and economical tools to provide relevant assessments of human health risk.

Combining an In Vitro Kinetic Model with a Physiologically-Based Pharmacokinetic Model to Assess the Potential In Vivo Fate of Polyvinyl Pyrrolidone-Vinyl Acetate Copolymers

Combining an In Vitro Kinetic Model with a Physiologically-Based Pharmacokinetic Model to Assess the Potential In Vivo Fate of Polyvinyl Pyrrolidone-Vinyl Acetate Copolymers

Publication: Pharm Res
Software: GastroPlus®

To understand hydrolysis and alcoholysis of polyvinylpyrrolidone-co-vinylacetate (PVPVA) during formulation and storage, elucidate the reaction mechanism, establish an intrinsic kinetic model, and apply...

Monitoring of erlotinib in pancreatic cancer patients during long-time administration and comparison to a physiologically based pharmacokinetic model

Monitoring of erlotinib in pancreatic cancer patients during long-time administration and comparison to a physiologically based pharmacokinetic model

Publication: Cancer Chemother Pharmacol

In this study, a therapeutic drug monitoring (TDM) of erlotinib in pancreatic cancer patients was performed over 50 weeks to reveal possible alterations in erlotinib plasma concentrations.

Advances in experimental and mechanistic computational models to understand pulmonary exposure to inhaled drugs.

Advances in experimental and mechanistic computational models to understand pulmonary exposure to inhaled drugs.

Publication: Eur J Pharm Sci
Software: GastroPlus®

Prediction of local exposure following inhalation of a locally acting pulmonary drug is central to the successful development of novel inhaled medicines, as well as generic equivalents.

In silico modeling to optimize interpretation of liver safety biomarkers in clinical trials

In silico modeling to optimize interpretation of liver safety biomarkers in clinical trials

Authors: Church R, Watkins PB
Publication: Exp Biol Med (Maywood)
Software: DILIsym®

Current strategies to delineate the risk of serious drug-induced liver injury associated with drugs rely on assessment of serum biomarkers that have been utilized for many decades.