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Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with non‐valvular atrial fibrillation from the RE‐LY trial
Summary.  Background: Dabigatran etexilate (DE) is an orally absorbed prodrug of dabigatran, a thrombin inhibitor that exerts potent anticoagulant and antithrombotic activity. Objectives: ToExpand
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A Phase I Dose Escalation Study with Anti-CD44v6 Bivatuzumab Mertansine in Patients with Incurable Squamous Cell Carcinoma of the Head and Neck or Esophagus
Purpose: To assess safety, pharmacokinetics, maximum tolerated dose, and preliminary efficacy of bivatuzumab mertansine. Bivatuzumab is a humanized monoclonal antibody directed against CD44v6, whichExpand
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Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation
This document was developed to enable greater consistency in the practice, application, and documentation of Model‐Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. AExpand
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Impact of Target‐Mediated Drug Disposition on Linagliptin Pharmacokinetics and DPP‐4 Inhibition in Type 2 Diabetic Patients
The pharmacokinetics of the novel dipeptidyl‐peptidase 4 (DPP‐4) inhibitor linagliptin is nonlinear. Based on in vitro experiments, concentration‐dependent binding to DPP‐4 is the most likely causeExpand
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Semi-mechanistic population pharmacokinetic/pharmacodynamic model for neutropenia following therapy with the Plk-1 inhibitor BI 2536 and its application in clinical development
Purpose(1) To describe the neutropenic response of BI 2536 a polo-like kinase 1 inhibitor in patients with cancer using a semi-mechanistic model. (2) To explore by simulations (a) the neutropenicExpand
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Pharmacometric Characterization of Dabigatran Hemodialysis
BackgroundHemodialysis has been shown to be a useful method of decreasing dabigatran plasma levels in situations that require rapid elimination of this thrombin inhibitor. However, there is currentlyExpand
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Contribution of the active metabolite M1 to the pharmacological activity of tesofensine in vivo: a pharmacokinetic‐pharmacodynamic modelling approach
Tesofensine is a centrally acting drug under clinical development for Alzheimer's disease, Parkinson's disease and obesity. In vitro, the major metabolite of tesofensine (M1) displayed a slightlyExpand
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Investigating pulmonary and systemic pharmacokinetics of inhaled olodaterol in healthy volunteers using a population pharmacokinetic approach.
AIMS Olodaterol, a novel β2-adrenergic receptor agonist, is a long-acting, once-daily inhaled bronchodilator approved for the treatment of chronic obstructive pulmonary disease. The aim of theExpand
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Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous Doses (0.5mg–10mg) and Determination of Absolute Bioavailability of the Dipeptidyl Peptidase-4 Inhibitor Linagliptin (BI 1356) in
Background and ObjectivesLinagliptin (BI 1356) is a highly specific inhibitor of dipeptidyl peptidase (DPP)-4, which is currently in phase III clinical development for the treatment of type 2Expand
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Integration of absorption, distribution, metabolism, and elimination genotyping data into a population pharmacokinetic analysis of nevirapine
We show the applicability of a newly developed algorithm to assess the influence of genetic variants on nevirapine’s drug disposition. Expand
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