Population pharmacokinetic analysis of axitinib in healthy volunteers.

Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 approved for second line treatment of advanced renal cell carcinoma. The objectives of this analysis were to assess plasma pharmacokinetics and identify covariates that may explain variability in axitinib disposition following single dose administration in healthy […]

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Axitinib in metastatic renal cell carcinoma: results of a pharmacokinetic and pharmacodynamic analysis.

Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, approved for second-line therapy for advanced renal cell carcinoma (RCC). Axitinib population pharmacokinetic and pharmacokinetic/pharmacodynamic relationships were evaluated. Using nonlinear mixed effects modeling with pooled data from 383 healthy volunteers, 181 patients with metastatic RCC, and 26 patients […]

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Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis

In this pharmacokinetic/pharmacodynamic meta-analysis, we investigated relationships between clinical endpoints and sunitinib exposure in patients with advanced solid tumors, including patients with gastrointestinal stromal tumor (GIST) and metastatic renal cell carcinoma (mRCC).

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Combining drug-disease and economic modelling to inform drug development decisions

Drug-disease models and clinical trial simulations are increasingly being used to support trial design and treatment optimization decisions.  Less widely recognized is their potential for guiding strategic development decisions.  These decisions require economic valuation of the potential product profile of efficacy, safety, ease of use, and so on.  This review presents a disguised case study […]

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Population Modeling of Modified Risk Tobacco Products

E-cigarette (e-cig) sales have surged in recent years. E-cigs, which deliver nicotine without carcinogenic tar, hold the promise to save the lives of many smokers who switch to them. However, their potential risks include failure to quit cigarettes (dual use), increased initiation to nicotine products among youth, relapse of former smokers to e-cigs, and e-cigs […]

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Population Modeling Helps Predict the Impact of E-cigarettes on Health

Bill Poland

The Oxford Dictionaries 2014 Word of the Year is “vape” – to inhale and exhale the vapor produced by an electronic cigarette (also known as e-cigarette or e-cig) or similar device. This choice reflects the meteoric rise in e-cig popularity. E-cigs, which deliver nicotine without carcinogenic tar, hold the promise to save the lives of […]

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Topics: Drug Safety
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