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
- Institución
- Universidad Nacional de La Plata
- OAI Identificador
- oai:sedici.unlp.edu.ar:10915/86668
Ver los metadatos del registro completo
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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 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Articulo http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
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article |
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http://sedici.unlp.edu.ar/handle/10915/86668 |
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openAccess |
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http://creativecommons.org/licenses/by-nc-sa/4.0/ Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) |
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