Titlebook: Dose Finding in Drug Development; Naitee Ting Book 2006 Springer-Verlag New York 2006 Maxima.Radiologieinformationssystem.clinical trial.c

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D. Graham Holmes,Christopher B. Lorenceients experiencing adverse events (AEs) unnecessarily (Herxheimer, 1991; ICH-E4, 1994). Over the last 5 years, a greater effort has been made to ensure that the best benefit to risk assessment is obtained for each new drug (Andrews and Dombeck, 2004; Bush et al., 2005). The benefit to risk assessmen

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Wolfgang Höhn,Torsten H. Franssonimately 10% mortality (the murine LD.). One-tenth or two-tenths of the murine equivalent of LD., expressed in milligrams per meters squared, is usually used as a starting dose in a Phase I trial. It is standard to choose a set of doses according to the modified Fibonacci sequence in which higher esc

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The Songs of Bush Crickets (Tettigoniidae),nse relationships. On the other hand, Phase III studies are designed to confirm findings from early phases, and results from Phase III studies are used for submission to regulatory agencies for drug approval. Hence, Phase III studies are designed for decision making. In terms of hypotheses testing,

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Gegenseitige Lage von Geraden und Ebenen,the world was to describe complicated phenomena using simple categories. Thus, it is hardly surprising that medical researchers often seek to categorize data in their attempt to make sense of unfamiliar measurement scales and treatment effects of uncertain implication. For this reason, threshold val

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https://doi.org/10.1007/978-94-011-9597-3nitial introduction of an investigational new drug in humans. The primary objectives are to (1) determine the metabolism and pharmacological activities of the drug, the side effects associated with increasing dose and early evidence in effectiveness and (2) obtain sufficient information regarding th