Bioequivalence: health, commercial and political implications of this technical tool

Autores
Ravera, Rosa Maria; Esitrin, Marcelo; Marin, Gustavo Horacio
Año de publicación
2024
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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.
Fil: Ravera, Rosa Maria. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina
Fil: Esitrin, Marcelo. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina
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
Materia
BIOEQUIVALENCE
KINETIC
SUBTITUTION
LIMITATIONS
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/230981
Acceder
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network_name_str CONICET Digital (CONICET)
spelling Bioequivalence: health, commercial and political implications of this technical toolRavera, Rosa MariaEsitrin, MarceloMarin, Gustavo HoracioBIOEQUIVALENCEKINETICSUBTITUTIONLIMITATIONShttps://purl.org/becyt/ford/3.1https://purl.org/becyt/ford/3Bioequivalence (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.Fil: Ravera, Rosa Maria. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; ArgentinaFil: Esitrin, Marcelo. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; ArgentinaFil: 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; ArgentinaCondonpublication2024-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/230981Ravera, 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; 1044-10532561-87411198-581XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.53555/jptcp.v31i1.3780info:eu-repo/semantics/altIdentifier/url/https://jptcp.com/index.php/jptcp/article/view/3780info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T09:46:35Zoai:ri.conicet.gov.ar:11336/230981instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-03 09:46:36.116CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Bioequivalence: health, commercial and political implications of this technical tool
title Bioequivalence: health, commercial and political implications of this technical tool
spellingShingle Bioequivalence: health, commercial and political implications of this technical tool
Ravera, Rosa Maria
BIOEQUIVALENCE
KINETIC
SUBTITUTION
LIMITATIONS
title_short Bioequivalence: health, commercial and political implications of this technical tool
title_full Bioequivalence: health, commercial and political implications of this technical tool
title_fullStr Bioequivalence: health, commercial and political implications of this technical tool
title_full_unstemmed Bioequivalence: health, commercial and political implications of this technical tool
title_sort Bioequivalence: health, commercial and political implications of this technical tool
dc.creator.none.fl_str_mv Ravera, Rosa Maria
Esitrin, Marcelo
Marin, Gustavo Horacio
author Ravera, Rosa Maria
author_facet Ravera, Rosa Maria
Esitrin, Marcelo
Marin, Gustavo Horacio
author_role author
author2 Esitrin, Marcelo
Marin, Gustavo Horacio
author2_role author
author
dc.subject.none.fl_str_mv BIOEQUIVALENCE
KINETIC
SUBTITUTION
LIMITATIONS
topic BIOEQUIVALENCE
KINETIC
SUBTITUTION
LIMITATIONS
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.1
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv 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.
Fil: Ravera, Rosa Maria. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina
Fil: Esitrin, Marcelo. Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica; Argentina
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
description 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.
publishDate 2024
dc.date.none.fl_str_mv 2024-01
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/230981
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
2561-8741
1198-581X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/230981
identifier_str_mv 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
2561-8741
1198-581X
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.53555/jptcp.v31i1.3780
info:eu-repo/semantics/altIdentifier/url/https://jptcp.com/index.php/jptcp/article/view/3780
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Condonpublication
publisher.none.fl_str_mv Condonpublication
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.13397

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