Scientific considerations in the review and approval of generic enoxaparin in the United States

In 2010, the US Food and Drug Administration (FDA) approved a generic low-molecular-weight heparin without clinical safety or efficacy data under the Abbreviated New Drug Application (ANDA) pathway. To enable a determination of active ingredient sameness of generic and innovator enoxaparin products,...

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Veröffentlicht in:	Nature biotechnology 2013-03, Vol.31 (3), p.220-226
Hauptverfasser:	Lee, Sau, Raw, Andre, Yu, Lawrence, Lionberger, Robert, Ya, Naiqi, Verthelyi, Daniela, Rosenberg, Amy, Kozlowski, Steve, Webber, Keith, Woodcock, Janet
Format:	Artikel
Sprache:	eng
Schlagworte:	631/154/155 692/699/75/567 Agriculture Bioinformatics Biomedical Engineering/Biotechnology Biomedicine Biotechnology Carbohydrate Sequence Clinical trials Dosage and administration Drug Approval Drugs, Generic - chemistry Enoxaparin Enoxaparin - chemistry Generic drugs Immunogenicity Licensing, certification and accreditation Life Sciences Methods Molecular Sequence Data Oligosaccharides - chemistry Patient safety perspective Pharmacology Physicochemical properties Thrombolytic drugs United States United States Food and Drug Administration
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