Titlebook: Cardiovascular Safety in Drug Development and Therapeutic Use; New Methodologies an J. Rick Turner,Dilip R. Karnad,Snehal Kothari Book 2017

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The Central Role of Cardiovascular Safety in Drug Development and Therapeutic Usethat are used to treat or prevent biological states of clinical concern. The term pharmaceutical drug typically refers to a small-molecule drug (around 20–100 atoms, with a molecular weight of less than 900 daltons), while the term biopharmaceutical drug refers to macromolecules, often a protein pro

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Drug Structures and the Biological Basis of Drug Responsesonsequently changing a patient’s biology for the better. Unfortunately, drugs can also lead to undesirable biological consequences, including adverse cardiovascular events. Before discussing the nature of these undesirable consequences and the methodologies for their prospective exclusion in subsequ

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Analyzing and Reporting Efficacy Data shining armor” that rides to our assistance and facilitates the collection, analysis, and interpretation of optimal-quality data as the basis for rational decision-making at all stages of the process (Durham and Turner 2008). In this and the following two chapters, we have resisted the temptation t

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Analyzing and Reporting Safety Data the focus moves to assessments of safety. As will be seen in the first part of this chapter, general safety assessments are conducted quite differently from those for efficacy, in that descriptive statistics are used as opposed to hypothesis testing. However, in the domain of cardiovascular safety,

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The Proarrhythmic Cardiac Safety Regulatory Landscape Circa 2005–2015: Drug-Induced hERG Channel Blol development whether a noncardiac drug has the propensity to lead to the polymorphic ventricular dysrhythmia . (Dessertenne 1966) in patients who may be prescribed the drug should it subsequently be approved for marketing. The second step is to remain alert to unexpected cardiac adverse drug reacti

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The Comprehensive In Vitro Proarrhythmia Assay Initiativetions of the nonclinical proarrhythmic cardiac safety regulatory landscape. Underlying this initiative is the fact that drug-induced .. reduction and QTc interval prolongation are far from ideal surrogates for actual proarrhythmic risk, the true concern in the domain of proarrhythmic cardiac safety.

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