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Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod

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dc.contributor.author Correale, Jorge
dc.contributor.author Chiquete, Erwin
dc.contributor.author Boyko, Alexey
dc.contributor.author Beran, Roy
dc.contributor.author Strauch, Jorge
dc.contributor.author Milojevic, Snezana
dc.contributor.author Frider, Nadina
dc.date.accessioned 2017-05-12T12:33:18Z
dc.date.available 2017-05-12T12:33:18Z
dc.date.issued 2016
dc.identifier.citation Drug Des Devel Ther. 2016 Jun 30;10:2109-17 es_CL
dc.identifier.uri http://dx.doi.org/10.2147/DDDT.S106802 es_CL
dc.identifier.uri http://hdl.handle.net/11447/1230
dc.description.abstract Both proprietary and nonproprietary medicines are expected to undergo rigorous preapproval testing and both should meet stringent health authority regulatory requirements related to quality to obtain approval. Nonproprietary (also known as copy, or generic) medicines, which base their authorization and use on the proprietary documentation and label, are often viewed as a means to help lower the cost and, thus, increase patient access. If these medicines fail to meet quality standards, such as good manufacturing practice and bioequivalence (in humans), they are then defined as substandard copies and can pose serious risks to patients in terms of safety and efficacy. Potentially noncontrolled or different manufacturing process and excipients in nonproprietary medicines may result in poor batch-to-batch reproducibility (accurate and consistent quantity of each ingredient in each capsule/tablet) and lower quality. Substandard, nonproprietary copies of medicines that are immunomodulatory or immunosuppressive are of concern to patients due to their possible untoward safety and lack of efficacy events. This article reviews the potential risks associated with nonproprietary medicines that do not meet the regulatory requirements of the United States Food and Drug Administration, the European Medicines Agency, or the World Health Organization. The clinical implications for patients are described. This article focuses on nonproprietary medicines for multiple sclerosis, particularly fingolimod, that are not identical to proprietary versions and could thus fail to meet efficacy expectations or have different impact on the safety of patients with multiple sclerosis. es_CL
dc.format.extent 9 es_CL
dc.language.iso en_US es_CL
dc.publisher Dove Press Limited es_CL
dc.subject bioequivalence es_CL
dc.subject fingolimod es_CL
dc.subject multiple sclerosis es_CL
dc.subject proprietary es_CL
dc.subject substandard copies es_CL
dc.subject toxicity es_CL
dc.title Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod es_CL
dc.type Artículo es_CL


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