Abstract
The requirements for drug approvability from a clinical viewpoint do not differ from those stated by the Food and Drug Administration. They should include documentation of symptomatic relief in patients with troublesome symptoms and/or documentation of the prevention or reduction of clinical complications associated with arrhythmias (eg. sudden cardiac death) and, moreover, evidence of safety and tolerability. The evaluation of antiarrhythmic compounds is complex and several methodological issues need to be considered.
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© 1989 Kluwer Academic Publishers
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Furberg, C.D. (1989). What do New Cardiovascular Agents (e.g. Antiarrhythmic Drugs) Have to Show to Establish a Favorable Risk versus Benefit Ratio to Obtain Approvability? — Clinical Viewpoint. In: Morganroth, J., Moore, E.N. (eds) Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents. Developments in Cardiovascular Medicine, vol 100. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1605-3_10
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DOI: https://doi.org/10.1007/978-1-4613-1605-3_10
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4612-8888-6
Online ISBN: 978-1-4613-1605-3
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