936 resultados para United States. Food and Drug Administration. Medical Library
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Low-molecular-weight heparins (LMWHs) have shown equivalent or superior efficacy and safety to unfractionated heparin as antithrombotic therapy for patients with acute coronary syndromes. Each approved LMWH is a pleotropic biological agent with a unique chemical, biochemical, biophysical and biological profile and displays different pharmacodynamic and pharmacokinetic profiles. As a result, LMWHs are neither equipotent in preclinical assays nor equivalent in terms of their clinical efficacy and safety. Previously, the US Food and Drug Administration (FDA) cautioned against using various LMWHs interchangeably, however recently, the FDA approved generic versions of LMWH that have not been tested in large clinical trials. This paper highlights the bio-chemical and pharmacological differences between the LMWH preparations that may result in different clinical outcomes, and also reviews the implications and challenges physicians face when generic versions of the original/innovator agents are approved for clinical use.
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Nos. 2986-15000, Aug. 3, 1914-June, 1927, issued as Supplements to Service and regulatory announcements of the Bureau of chemistry. Beginning with no. 3501, Apr. 3, 1915, Supplements are numbered consecutively S.R.A. Chem. suppl. 1-230.
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Includes bibliographical references.
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Kept up-to-date by revised pages which are inserted.
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Mode of access: Internet.