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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 – 2013年8月1日 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

Certara’s Simcyp Appoints Professor Yuichi Sugiyama to the Certara Scientific Advisory Board

The appointment will help Simcyp maintain and enhance its leadership in the field of predictive pharmacokinetic modelling and simulation. ST. LOUIS, MO – 2013年6月5日 Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, announced that Simcyp Limited, a Certara company and … Continued

Application of In Vitro-In Vivo Extrapolation (IVIVE) and Physiologically-based Pharmacokinetic Modeling to Investigate the Impact of the CYP2C8 Polymorphism on Rosiglitazone Exposure

The purpose of this study was to predict the impact of the CYP2C8*3 genotype on rosiglitazone exposure in the absence and presence of trimethoprim. Prior in vitro and in vivo information for rosiglitazone and trimethoprim were collated from the literature. Specifically, data on the frequency of the different allelic forms of CYP2C8 and their metabolic … Continued

Physiologically-based Pharmacokinetic Models for Everolimus and Sorafenib in Mice

Everolimus is a mammalian target of rapamycin (mTOR) inhibitor approved as an immunosuppressant and for second-line therapy of hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC). Sorafenib is a multikinase inhibitor used as first-line therapy in HCC and RCC. This study assessed the pharmacokinetics (PK) of everolimus and sorafenib alone and in combination in plasma … Continued

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