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Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part I—Digoxin Pharmacokinetic Incorporating P-glycoprotein-mediated Efflux

A prerequisite for the prediction of the magnitude of P-glycoprotein (P-gp)-mediated drug-drug interactions between digoxin and P-gp inhibitors (e.g. verapamil and its metabolite norverapamil) or P-gp inducers (e.g. rifampicin) is a predictive pharmacokinetic model for digoxin itself. Thus, relevant in vitro metabolic, transporter and inhibitory data incorporated into permeability-limited models, such as the “advanced dissolution, … Continued

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

Digoxin is the recommended substrate for assessment of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) in vivo. The overall aim of our study was to investigate the inhibitory potential of both verapamil and norverapamil on the P-gp-mediated efflux of digoxin in both gut and liver. Therefore, a physiologically-based pharmacokinetic (PBPK) model for verapamil and its primary metabolite … Continued

Simcyp Releases Version 13 of its Widely Used Simulator

New release further expands biologics capabilities and provides new tools for formulation scientists ST. LOUIS, MO – Aug. 28, 2013 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, today announced that version 13 of its Simcyp™ Simulator has now been released, … Continued

Certara Launches Cardiac Safety Simulator to Help Assess New Drug Candidates’ Arrhythmia Risk

Simulator helps sponsors to assess arrhythmia risk before a candidate enters clinical trials; determine safe drug doses for specific patient populations ST. LOUIS, MO – August 1, 2013 Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, today announced the launch of its Cardiac … Continued

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