Prediction of Safety Margin and Optimization of Dosing Protocol for a Novel Antibiotic using Quantitative Systems Pharmacology Modeling

Prediction of Safety Margin and Optimization of Dosing Protocol for a Novel Antibiotic using Quantitative Systems Pharmacology Modeling

Publication: Clin Transl Sci
Software: DILIsym®

Elevations of liver enzymes have been observed in clinical trials with BAL30072, a novel antibiotic. In vitro assays have identified potential mechanisms for the observed hepatotoxicity, including...

Evaluation and Optimization of Pharmacokinetic Models for in Vitro to in Vivo Extrapolation of Estrogenic Activity for Environmental Chemicals

Evaluation and Optimization of Pharmacokinetic Models for in Vitro to in Vivo Extrapolation of Estrogenic Activity for Environmental Chemicals

Publication: Environ Health Perspect
Software: GastroPlus®

To effectively incorporate in vitro data into regulatory use, confidence must be established in the quantitative extrapolation of in vitro activity to relevant end...

Preclinical models for colonic absorption, application to controlled release formulation development

Preclinical models for colonic absorption, application to controlled release formulation development

Publication: Eur J Pharm Biopharm
Software: GastroPlus®

Oral controlled release (CR) formulations have many benefits and have become a valuable resource for the local and systemic administration of drugs.

Discussions on the hepatic well-stirred model: Re-derivation from the dispersion model and re-analysis of the lidocaine data

Discussions on the hepatic well-stirred model: Re-derivation from the dispersion model and re-analysis of the lidocaine data

Authors: Dong J, Park MS
Publication: Eur J Pharm Sci
Division: PBPK

Roberts and Rowland explained the well-stirred model as an extreme case of the dispersion model when the dispersion number is infinity.

Characterization of solution stress degradation products of aliskiren and prediction of their physicochemical and ADMET properties

Characterization of solution stress degradation products of aliskiren and prediction of their physicochemical and ADMET properties

Publication: Eur J Pharm Sci
Software: ADMET Predictor®

Forced degradation studies on aliskiren were carried out according to ICH and WHO guidelines. Six degradation products were formed in total in the solution state.

A bifunctional nociceptin and mu opioid receptor agonist is analgesic without opioid side effects in nonhuman primates

A bifunctional nociceptin and mu opioid receptor agonist is analgesic without opioid side effects in nonhuman primates

Publication: Science Translational Medicine
Software: ADMET Predictor®
Division: Cheminformatics

Misuse of prescription opioids, opioid addiction, and overdose underscore the urgent need for developing addiction-free effective medications for treating severe pain.

Retention characteristics of some antibiotic and anti-retroviral compounds in hydrophilic interaction chromatography using isocratic elution, and gradient elution with repeatable partial equilibration

Retention characteristics of some antibiotic and anti-retroviral compounds in hydrophilic interaction chromatography using isocratic elution, and gradient elution with repeatable partial equilibration

Publication: Analytica Chimica Acta
Software: ADMET Predictor®

The separation of some zwitterionic, basic and neutral antibiotic and antiretroviral compounds was studied using hydrophilic interaction chromatography (HILIC) on bare silica, bonded amide and urea superficially porous phases.

Physiological Considerations and In Vitro Strategies for Evaluating the Influence of Food on Drug Release from Extended-Release Formulations

Physiological Considerations and In Vitro Strategies for Evaluating the Influence of Food on Drug Release from Extended-Release Formulations

Publication: AAPS PharmSciTech

Food effects on oral drug bioavailability are a consequence of the complex interplay between drug, formulation and human gastrointestinal (GI) physiology.

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

Publication: AAPS J
Software: GastroPlus®
Division: PBPK

This publication summarizes the proceedings of day 3 of a 3-day workshop on “Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development.”

Impact of Drug Physicochemical Properties on Lipolysis-triggered Drug Supersaturation and Precipitation from Lipid-Based Formulations

Impact of Drug Physicochemical Properties on Lipolysis-triggered Drug Supersaturation and Precipitation from Lipid-Based Formulations

Publication: Mol Pharm
Software: ADMET Predictor®

In this study we investigated lipolysis-triggered supersaturation and precipitation of a set of model compounds formulated in lipid-based formulations (LBFs).

Assessing the potential of solid dispersions to improve dissolution rate and bioavailability of valsartan: In vitro-in silico approach

Assessing the potential of solid dispersions to improve dissolution rate and bioavailability of valsartan: In vitro-in silico approach

Publication: Eur J Pharm Sci
Software: GastroPlus®

This study aimed to improve dissolution rate of valsartan in an acidic environment and consequently its oral bioavailability by solid dispersion formulation.

Using DILIsym, A Quantitative Systems Toxicology (QST) Software Tool of Drug-Induced Liver Injury (DILI), To Assess DILI Risk in Drug Development

Using DILIsym, A Quantitative Systems Toxicology (QST) Software Tool of Drug-Induced Liver Injury (DILI), To Assess DILI Risk in Drug Development

Authors: Howell BA
Conference: BIT IDDST
Software: DILIsym®

A combination of multiple mechanistic, in silico modeling approaches can facilitate drug discovery (QSAR, PBPK, QSP and QST).

Introducing a computational method to estimate and prioritize systemic body exposure of organic chemicals in humans using their physicochemical properties

Introducing a computational method to estimate and prioritize systemic body exposure of organic chemicals in humans using their physicochemical properties

Authors: Matthews EJ
Publication: Computational Toxicology
Software: ADMET Predictor®

This report describes a computational method developed to predict systemic exposure (s-exposure), chemical disposition {(CD) intestinal absorption, transport, membrane permeability, distribution...

Identification of chemically diverse GABAA agonists as potential anti-epileptic agents using structure-guided virtual screening, ADMET, quantum mechanics and clinical validation through off-target analysis

Identification of chemically diverse GABAA agonists as potential anti-epileptic agents using structure-guided virtual screening, ADMET, quantum mechanics and clinical validation through off-target analysis

Publication: Int J Biol Macromol
Keywords: toxicity analysis
Software: ADMET Predictor®

Development of resistance against existing anti-epileptic drugs has alarmed the scientific innovators to find novel potential chemical starting points for the treatment of epilepsy and GABAA inhibition is a promising...

Synthesis of Proline Derived Benzenesulfonamides: A Potent Anti-Trypanosoma Brucei Gambiense Agent

Synthesis of Proline Derived Benzenesulfonamides: A Potent Anti-Trypanosoma Brucei Gambiense Agent

Publication: In Silico Pharmacol

Thousands of death in Africa and other developing nations are still attributed to trypanosomiasis. Excessive sleep has been associated with increased inflammation. We report herein, the synthesis…