Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants

Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants

Publication: Clin Pharmacokinet
Software: GastroPlus®

Physiologically based pharmacokinetic (PBPK) modelling can assist in the development of drug therapies and regimens suitable for challenging patient populations such as very young children.

In Vitro and In Silico Strategies to Identify OATP1B1 Inhibitors and Predict Clinical Drug–Drug Interactions

In Vitro and In Silico Strategies to Identify OATP1B1 Inhibitors and Predict Clinical Drug–Drug Interactions

Publication: Pharm Res
Software: ADMET Predictor®

To establish in vitro and in silico models that predict clinical drug–drug interactions (DDIs) with the OATP1B1 (SLCO1B1) transporter.

Selection of oral bioavailability enhancing formulations during drug discovery

Selection of oral bioavailability enhancing formulations during drug discovery

Publication: Drug Dev Ind Pharm
Software: GastroPlus®

The objective of this paper was to identify oral bioavailability enhancing approaches for a poorly water-soluble research compound during drug discovery stages using minimal amounts of material.

Pre-clinical and clinical pharmacokinetics of PF-02413873, a non-steroidal progesterone receptor antagonist

Pre-clinical and clinical pharmacokinetics of PF-02413873, a non-steroidal progesterone receptor antagonist

Publication: Drug Metab Dispos
Software: GastroPlus®

The recently discovered selective nonsteroidal progesterone receptor (PR) antagonist 4-[3-cyclopropyl-1-(methylsulfonylmethyl)-5-methyl-1H-pyrazol-4-yl]oxy-2,6-dimethylbenzonitrile (PF-02413873)...

The Application of Physiologically Based Pharmacokinetic Modelling to Understanding the Clinical Pharmacokinetics of UK-369,003

The Application of Physiologically Based Pharmacokinetic Modelling to Understanding the Clinical Pharmacokinetics of UK-369,003

Publication: Drug Metab Dispos
Software: GastroPlus®

5-[2-Ethoxy-5-(4-ethyl-piperazine-1-sulfonyl)-pyridin-3-yl]-3-ethyl-2-(2-methoxy-ethyl)-2,6-dihydro-pyrazolo[4,3-d]pyrimidin-7-one (UK-369,003) is a phosphodiesterase-5...

Physiological modeling and assessments of regional drug bioavailability of danoprevir to determine whether a controlled release formulation is feasible

Physiological modeling and assessments of regional drug bioavailability of danoprevir to determine whether a controlled release formulation is feasible

Publication: Biopharm Drug Dispos
Software: GastroPlus®

Danoprevir, a potent, selective inhibitor of HCV NS3/4A protease, has a short half-life in humans. Therefore, the feasibility of a controlled release (CR) formulation to allow less frequent dosing...

In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation.

In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation.

Publication: AAPS PharmSciTech
Software: GastroPlus®

The aim of this study was to develop a drug-specific absorption model for gliclazide (GLK) using mechanistic gastrointestinal simulation technology (GIST) implemented...

Use of structure-activity landscape index curves and curve integrals to evaluate the performance of multiple machine learning prediction models

Use of structure-activity landscape index curves and curve integrals to evaluate the performance of multiple machine learning prediction models

Publication: J Cheminform
Software: ADMET Predictor®

Standard approaches to address the performance of predictive models that used common statistical measurements for the entire data set provide an overview of...

Bendamustine pharmacokinetic profile and exposure-response relationships in patients with indolent non-Hodgkin’s lymphoma

Bendamustine pharmacokinetic profile and exposure-response relationships in patients with indolent non-Hodgkin’s lymphoma

Publication: Cancer Chemother Pharmacol
Division: Cognigen

The pharmacokinetic profiles of bendamustine and active metabolites were defined in patients with rituximab-refractory, relapsed indolent B-cell non-Hodgkin's lymphoma, and supported understanding of exposure-response relationships for efficacy and safety.

Dissolution modeling of bead formulations and predictions of bioequivalence for a highly soluble, highly permeable drug

Dissolution modeling of bead formulations and predictions of bioequivalence for a highly soluble, highly permeable drug

Publication: Mol Pharm
Software: GastroPlus®

The objective of this study was to assess the impact of observed in vitro dissolution rate differences on in vivo pharmacokinetics for two enteric-coated bead formulations...

The biowaivers extension for BCS Class III drugs: the effect of dissolution rate on on the bioequivalence of BCS Class III IR drugs predicted by computer simulation

The biowaivers extension for BCS Class III drugs: the effect of dissolution rate on on the bioequivalence of BCS Class III IR drugs predicted by computer simulation

Authors: Tsume Y, Amidon GL
Publication: Mol Pharm
Software: GastroPlus®

The Biopharmaceutical Classification System (BCS) guidance issued by the FDA allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release...

In Silico Classification of Major Clearance Pathways of Drugs with Their Physiochemical Parameters

In Silico Classification of Major Clearance Pathways of Drugs with Their Physiochemical Parameters

Publication: Drug Metab Dispos
Software: ADMET Predictor®

Predicting major clearance pathways of drugs is important in understanding their pharmacokinetic properties in clinical use, such as drug-drug interactions and genetic...

Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects

Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects

Publication: Clin Pharmacol Ther
Division: Cognigen

Intravenous (IV) iron is used to treat iron-deficiency anemia in patients with chronic kidney disease (CKD). Ferumoxytol is a novel iron formulation administered rapidly as two IV boluses of 510 mg each. In this placebo-controlled, double-blind...