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

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...

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Detalles Bibliográficos
Autores principales: Cristofoletti, Rodrigo, Shah, Vinod P., Langguth, Peter, Polli, James E., Mehta, Mehul, Abrahamsson, Bertil, Dressman, Jennifer B., Quiroga, Pablo
Formato: Articulo
Lenguaje:Inglés
Publicado: 2015
Materias:
Farmacia
BCS-based biowaiver
Generic drug
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/86668
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-86668
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
BCS-based biowaiver
Generic drug
spellingShingle Farmacia
BCS-based biowaiver
Generic drug
Cristofoletti, Rodrigo
Shah, Vinod P.
Langguth, Peter
Polli, James E.
Mehta, Mehul
Abrahamsson, Bertil
Dressman, Jennifer B.
Quiroga, Pablo
Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
topic_facet Farmacia
BCS-based biowaiver
Generic drug
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
format Articulo
Articulo
author Cristofoletti, Rodrigo
Shah, Vinod P.
Langguth, Peter
Polli, James E.
Mehta, Mehul
Abrahamsson, Bertil
Dressman, Jennifer B.
Quiroga, Pablo
author_facet Cristofoletti, Rodrigo
Shah, Vinod P.
Langguth, Peter
Polli, James E.
Mehta, Mehul
Abrahamsson, Bertil
Dressman, Jennifer B.
Quiroga, Pablo
author_sort Cristofoletti, Rodrigo
title Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS)
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)
publishDate 2015
url http://sedici.unlp.edu.ar/handle/10915/86668
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