Scientific considerations in the review and approval of generic enoxaparin in the United States.
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Physicians' Trust in the FDA's Use of Product-Specific Pathways for Generic Drug ApprovalConsistency of quality attributes for the glycosylated monoclonal antibody Humira® (adalimumab).Homogeneous low-molecular-weight heparins with reversible anticoagulant activity.Evaluation of Immunostimulatory Potential of Branded and US-Generic Enoxaparins in an In Vitro Human Immune System Model.Detection of innate immune response modulating impurities in therapeutic proteinsThe Botanical Drug Substance Crofelemer as a Model System for Comparative Characterization of Complex Mixture Drugs.Do patients trust the FDA?: a survey assessing how patients view the generic drug approval process.Comparative analysis of INLIGHT™-labeled enzymatically depolymerized heparin by reverse-phase chromatography and high-performance mass spectrometry.Modernization of Enoxaparin Molecular Weight Determination Using Homogeneous Standards.Combining measurements to estimate properties and characterization extent of complex biochemical mixtures; applications to Heparan Sulfate.Immunology careers at the NIH, FDA and CDC: different paths that focus on advancing public health.Synthetic oligosaccharides can replace animal-sourced low-molecular weight heparins.
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Scientific considerations in the review and approval of generic enoxaparin in the United States.
description
article científic
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article scientifique
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articol științific
@ro
articolo scientifico
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artigo científico
@gl
artigo científico
@pt
artigo científico
@pt-br
artikel ilmiah
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artikull shkencor
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artículo científico
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name
Scientific considerations in t ...... oxaparin in the United States.
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type
label
Scientific considerations in t ...... oxaparin in the United States.
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prefLabel
Scientific considerations in t ...... oxaparin in the United States.
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P2093
P2860
P356
P1433
P1476
Scientific considerations in t ...... oxaparin in the United States.
@en
P2093
Amy Rosenberg
Daniela Verthelyi
Janet Woodcock
Keith Webber
Lawrence Yu
Robert Lionberger
Steve Kozlowski
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P2888
P304
P356
10.1038/NBT.2528
P577
2013-03-01T00:00:00Z