Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)

Autores
Cristofoletti, Rodrigo; Shah, Vinod P.; Langguth, Peter; Polli, James E.; Mehta, Mehul; Abrahamsson, Bertil; Dressman, Jennifer B.; Quiroga, Pablo
Año de publicación
2015
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Even though the pivotal article stating the theoretical basis for a biopharmaceutics drug classification (1) was published almost 20 years ago, the extension of BCS-based biowaiver decisions to drugs belonging to BCS classes other than those showing high solubility and high permeability has not yet reached a consensus among regulators, industrial scientists, and academics. Also, within some jurisdictions, BCS principles have not yet been incorporated into legal frameworks and thus have not been used to allow science- and risk-based regulatory flexibility. This report provides a brief description of the presentations from the International Workshop on Implementation of Biowaivers based on the BCS in Buenos Aires, Argentina, that took place on March 5–6, 2015. The meeting was cosponsored by National University of La Plata, Confederación Farmacéutica Argentina, International Pharmaceutical Federation (FIP), and the American Association of Pharmaceutical Scientists (AAPS). The main objectives of the meeting were to describe the state of the art with respect to in vitro and in silico tools to support waiving in vivo bioequivalence studies and to foster discussion about implementing BCS-based biowaiver decisions to support generic drug registration in South America. Two hundred and fifteen scientists from universities, the pharmaceutical industry, and regulatory authorities took part in this meeting
Facultad de Ciencias Exactas
Materia
Farmacia
BCS-based biowaiver
Generic drug
Nivel de accesibilidad
acceso abierto
Condiciones de uso
http://creativecommons.org/licenses/by-nc-sa/4.0/
Repositorio
SEDICI (UNLP)
Institución
Universidad Nacional de La Plata
OAI Identificador
oai:sedici.unlp.edu.ar:10915/86668

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spelling Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)Cristofoletti, RodrigoShah, Vinod P.Langguth, PeterPolli, James E.Mehta, MehulAbrahamsson, BertilDressman, Jennifer B.Quiroga, PabloFarmaciaBCS-based biowaiverGeneric drugEven though the pivotal article stating the theoretical basis for a biopharmaceutics drug classification (1) was published almost 20 years ago, the extension of BCS-based biowaiver decisions to drugs belonging to BCS classes other than those showing high solubility and high permeability has not yet reached a consensus among regulators, industrial scientists, and academics. Also, within some jurisdictions, BCS principles have not yet been incorporated into legal frameworks and thus have not been used to allow science- and risk-based regulatory flexibility. This report provides a brief description of the presentations from the International Workshop on Implementation of Biowaivers based on the BCS in Buenos Aires, Argentina, that took place on March 5–6, 2015. The meeting was cosponsored by National University of La Plata, Confederación Farmacéutica Argentina, International Pharmaceutical Federation (FIP), and the American Association of Pharmaceutical Scientists (AAPS). The main objectives of the meeting were to describe the state of the art with respect to in vitro and in silico tools to support waiving in vivo bioequivalence studies and to foster discussion about implementing BCS-based biowaiver decisions to support generic drug registration in South America. Two hundred and fifteen scientists from universities, the pharmaceutical industry, and regulatory authorities took part in this meetingFacultad de Ciencias Exactas2015info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionArticulohttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdf77-81http://sedici.unlp.edu.ar/handle/10915/86668enginfo:eu-repo/semantics/altIdentifier/issn/1521-298Xinfo:eu-repo/semantics/altIdentifier/doi/10.14227/DT220215P77info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc-sa/4.0/Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0)reponame:SEDICI (UNLP)instname:Universidad Nacional de La Platainstacron:UNLP2025-09-29T11:17:00Zoai:sedici.unlp.edu.ar:10915/86668Institucionalhttp://sedici.unlp.edu.ar/Universidad públicaNo correspondehttp://sedici.unlp.edu.ar/oai/snrdalira@sedici.unlp.edu.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:13292025-09-29 11:17:00.394SEDICI (UNLP) - Universidad Nacional de La Platafalse
dc.title.none.fl_str_mv Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
title Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
spellingShingle Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
Cristofoletti, Rodrigo
Farmacia
BCS-based biowaiver
Generic drug
title_short Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
title_full Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
title_fullStr Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
title_full_unstemmed Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
title_sort Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
dc.creator.none.fl_str_mv Cristofoletti, Rodrigo
Shah, Vinod P.
Langguth, Peter
Polli, James E.
Mehta, Mehul
Abrahamsson, Bertil
Dressman, Jennifer B.
Quiroga, Pablo
author Cristofoletti, Rodrigo
author_facet Cristofoletti, Rodrigo
Shah, Vinod P.
Langguth, Peter
Polli, James E.
Mehta, Mehul
Abrahamsson, Bertil
Dressman, Jennifer B.
Quiroga, Pablo
author_role author
author2 Shah, Vinod P.
Langguth, Peter
Polli, James E.
Mehta, Mehul
Abrahamsson, Bertil
Dressman, Jennifer B.
Quiroga, Pablo
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Farmacia
BCS-based biowaiver
Generic drug
topic Farmacia
BCS-based biowaiver
Generic drug
dc.description.none.fl_txt_mv Even though the pivotal article stating the theoretical basis for a biopharmaceutics drug classification (1) was published almost 20 years ago, the extension of BCS-based biowaiver decisions to drugs belonging to BCS classes other than those showing high solubility and high permeability has not yet reached a consensus among regulators, industrial scientists, and academics. Also, within some jurisdictions, BCS principles have not yet been incorporated into legal frameworks and thus have not been used to allow science- and risk-based regulatory flexibility. This report provides a brief description of the presentations from the International Workshop on Implementation of Biowaivers based on the BCS in Buenos Aires, Argentina, that took place on March 5–6, 2015. The meeting was cosponsored by National University of La Plata, Confederación Farmacéutica Argentina, International Pharmaceutical Federation (FIP), and the American Association of Pharmaceutical Scientists (AAPS). The main objectives of the meeting were to describe the state of the art with respect to in vitro and in silico tools to support waiving in vivo bioequivalence studies and to foster discussion about implementing BCS-based biowaiver decisions to support generic drug registration in South America. Two hundred and fifteen scientists from universities, the pharmaceutical industry, and regulatory authorities took part in this meeting
Facultad de Ciencias Exactas
description Even though the pivotal article stating the theoretical basis for a biopharmaceutics drug classification (1) was published almost 20 years ago, the extension of BCS-based biowaiver decisions to drugs belonging to BCS classes other than those showing high solubility and high permeability has not yet reached a consensus among regulators, industrial scientists, and academics. Also, within some jurisdictions, BCS principles have not yet been incorporated into legal frameworks and thus have not been used to allow science- and risk-based regulatory flexibility. This report provides a brief description of the presentations from the International Workshop on Implementation of Biowaivers based on the BCS in Buenos Aires, Argentina, that took place on March 5–6, 2015. The meeting was cosponsored by National University of La Plata, Confederación Farmacéutica Argentina, International Pharmaceutical Federation (FIP), and the American Association of Pharmaceutical Scientists (AAPS). The main objectives of the meeting were to describe the state of the art with respect to in vitro and in silico tools to support waiving in vivo bioequivalence studies and to foster discussion about implementing BCS-based biowaiver decisions to support generic drug registration in South America. Two hundred and fifteen scientists from universities, the pharmaceutical industry, and regulatory authorities took part in this meeting
publishDate 2015
dc.date.none.fl_str_mv 2015
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
Articulo
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://sedici.unlp.edu.ar/handle/10915/86668
url http://sedici.unlp.edu.ar/handle/10915/86668
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/issn/1521-298X
info:eu-repo/semantics/altIdentifier/doi/10.14227/DT220215P77
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
http://creativecommons.org/licenses/by-nc-sa/4.0/
Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0)
eu_rights_str_mv openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-sa/4.0/
Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0)
dc.format.none.fl_str_mv application/pdf
77-81
dc.source.none.fl_str_mv reponame:SEDICI (UNLP)
instname:Universidad Nacional de La Plata
instacron:UNLP
reponame_str SEDICI (UNLP)
collection SEDICI (UNLP)
instname_str Universidad Nacional de La Plata
instacron_str UNLP
institution UNLP
repository.name.fl_str_mv SEDICI (UNLP) - Universidad Nacional de La Plata
repository.mail.fl_str_mv alira@sedici.unlp.edu.ar
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