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Nonclinical in vivo animal studies have to be completed before starting clinical studies of the pharmacokinetic behavior of a drug in humans. The drug exposure in animal studies is often measured by the area under the concentration time curve (AUC). The classical complete data design where each animal is sampled for analysis once per time point is usually(More)
Pharmacokinetic studies are commonly performed using the two-stage approach. The first stage involves estimation of pharmacokinetic parameters such as the area under the concentration versus time curve (AUC) for each analysis subject separately, and the second stage uses the individual parameter estimates for statistical inference. This two-stage approach(More)
Statistical comparison of organ weights between treated and untreated animals have traditionally been used to predict potential toxicity for patients. The manner of presentation of organ weight data, and the value of statistical analyses have been topics of discussion. Historically, a decision tree approach has been applied for statistical comparison of(More)
A bootstrap based method to construct 1 − α simultaneous confidence intervals for relative effects in the one-way layout is presented. This procedure takes the stochastic correlation between the test statistics into account and results in narrower simultaneous confidence intervals than the application of the Bon-ferroni correction. Instead of using the(More)
Bioequivalence between two products has to be demonstrated as an essential part of the generic approval process (new formulation vs. innovator product), bridging an innovator's product from the formulation used in clinical phase III to the marketed formulation, or in case of major variations of an approved product. The most common design of bioequivalence(More)
BACKGROUND Platelet inhibitors are commonly used to reduce the risk of atherothrombotic events. The aim of this study was to determine the impact of platelet inhibitors, specifically clopidogrel and aspirin, on clot kinetics, strength, and/or structure during the use of thrombin based gelatin matrices and fibrin sealants. METHODS Blood was collected and(More)
Estimating pharmacokinetic parameters in the presence of an endogenous concentration is not straightforward as cross-reactivity in the analytical methodology prevents differentiation between endogenous and dose-related exogenous concentrations. This article proposes a novel intuitive modeling approach which adequately adjusts for the endogenous(More)
Blood loss during hepatic surgery leads to poor patient outcomes. This study investigates the hemostatic efficacy of a novel sealing hemostatic pad (polyethylene glycol-coated collagen, PCC) and a fibrin sealant pad (fibrin-thrombin coated collagen, FTC) in a leporine hepatic segmentectomy and a porcine hepatic abrasion model. A segmentectomy was used to(More)
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