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dc.contributor.author
Ravera, Rosa Maria
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dc.contributor.author
Esitrin, Marcelo
dc.contributor.author
Marin, Gustavo Horacio
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dc.date.available
2024-03-20T11:58:26Z
dc.date.issued
2024-01
dc.identifier.citation
Ravera, Rosa Maria; Esitrin, Marcelo; Marin, Gustavo Horacio; Bioequivalence: health, commercial and political implications of this technical tool; Condonpublication; Journal of Population Therapeutics and Clinical Pharmacology; 31; 1; 1-2024; 1044-1053
dc.identifier.issn
2561-8741
dc.identifier.uri
http://hdl.handle.net/11336/230981
dc.description.abstract
Bioequivalence (BE) is a clinical-pharmacological research method that has acquired great relevancein most of the countries due to its health, commercial, and political importance. Some regulatoryagencies require routine BE for all products registered in their national territory, while others opt forpolicies that require this study only for certain products. The truth is that even today there are currentdebates about its definition, its clinical relevance and the level of requirements that each country mustask to those companies that aim to register a new product.The objective of this paper is to provide different perspectives on the concept of bioequivalent drugs,establish what are the advantages or disadvantages of adopting different policies on BE, identify theinterests associated with this concept and clarify its real importance for public health.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Condonpublication
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc/2.5/ar/
dc.subject
BIOEQUIVALENCE
dc.subject
KINETIC
dc.subject
SUBTITUTION
dc.subject
LIMITATIONS
dc.subject.classification
Farmacología y Farmacia
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dc.subject.classification
Medicina Básica
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dc.subject.classification
CIENCIAS MÉDICAS Y DE LA SALUD
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dc.title
Bioequivalence: health, commercial and political implications of this technical tool
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2024-03-19T14:26:47Z
dc.identifier.eissn
1198-581X
dc.journal.volume
31
dc.journal.number
1
dc.journal.pagination
1044-1053
dc.journal.pais
Canadá
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dc.journal.ciudad
Otawa
dc.description.fil
Fil: Ravera, Rosa Maria. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina
dc.description.fil
Fil: Esitrin, Marcelo. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina
dc.description.fil
Fil: Marin, Gustavo Horacio. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Departamento de Articulación de Ciencias Básicas y Clínicas; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina
dc.journal.title
Journal of Population Therapeutics and Clinical Pharmacology
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.53555/jptcp.v31i1.3780
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://jptcp.com/index.php/jptcp/article/view/3780
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