Innovative in vitro methodologies for establishing therapeutic equivalence
ABSTRACT To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely...
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ftdoajarticles:oai:doaj.org/article:6024aa09fa994875886a575be0bf3991 2023-05-15T15:11:31+02:00 Innovative in vitro methodologies for establishing therapeutic equivalence Lisa Murray Antonio Arias Jibin Li Sid Bhoopathy Ismael J. Hidalgo https://doaj.org/article/6024aa09fa994875886a575be0bf3991 EN ES PT eng spa por Pan American Health Organization http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000700023&lng=en&tlng=en https://doaj.org/toc/1680-5348 1680-5348 https://doaj.org/article/6024aa09fa994875886a575be0bf3991 Revista Panamericana de Salud Pública, Vol 40, Iss 1, Pp 23-28 Biofarmacéutica disolución permeabilidad absorción equivalencia terapéutica control de calidad Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article ftdoajarticles 2022-12-31T14:03:05Z ABSTRACT To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely on clinical studies to comply with this requirement. Instead, it makes sense to adopt or develop strategies that are appropriate to the characteristics of the region. To streamline drug development and accelerate patients’ access to quality drug products, 15 years ago the United States Food and Drug Administration (FDA) decided to grant exemptions from clinical bioequivalence studies (i.e., biowaivers) for certain types of drug products based on the Biopharmaceutics Classification System (BCS). Biowaivers can significantly reduce development time and cost and can also prevent unnecessary human exposure to potentially dangerous drugs while providing a robust, consistent standard for therapeutic equivalence of generic drug products. In addition, the limited success of translating in vitro dissolution data into in vivo performance can be enhanced using innovative tools such as the in vitro dissolution and absorption systems (IDAS). By integrating in vitro dissolution and permeability tests, these systems can provide useful insights for formulation development. A thorough assessment of the potential of in vitro techniques, along with formalization of their use through regulatory science initiatives when appropriate, may lead to cost-effective tools to help address some of the quality and regulatory challenges faced in the Latin American and Caribbean region. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic |
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Directory of Open Access Journals: DOAJ Articles |
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English Spanish Portuguese |
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Biofarmacéutica disolución permeabilidad absorción equivalencia terapéutica control de calidad Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Biofarmacéutica disolución permeabilidad absorción equivalencia terapéutica control de calidad Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Lisa Murray Antonio Arias Jibin Li Sid Bhoopathy Ismael J. Hidalgo Innovative in vitro methodologies for establishing therapeutic equivalence |
topic_facet |
Biofarmacéutica disolución permeabilidad absorción equivalencia terapéutica control de calidad Medicine R Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
ABSTRACT To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely on clinical studies to comply with this requirement. Instead, it makes sense to adopt or develop strategies that are appropriate to the characteristics of the region. To streamline drug development and accelerate patients’ access to quality drug products, 15 years ago the United States Food and Drug Administration (FDA) decided to grant exemptions from clinical bioequivalence studies (i.e., biowaivers) for certain types of drug products based on the Biopharmaceutics Classification System (BCS). Biowaivers can significantly reduce development time and cost and can also prevent unnecessary human exposure to potentially dangerous drugs while providing a robust, consistent standard for therapeutic equivalence of generic drug products. In addition, the limited success of translating in vitro dissolution data into in vivo performance can be enhanced using innovative tools such as the in vitro dissolution and absorption systems (IDAS). By integrating in vitro dissolution and permeability tests, these systems can provide useful insights for formulation development. A thorough assessment of the potential of in vitro techniques, along with formalization of their use through regulatory science initiatives when appropriate, may lead to cost-effective tools to help address some of the quality and regulatory challenges faced in the Latin American and Caribbean region. |
format |
Article in Journal/Newspaper |
author |
Lisa Murray Antonio Arias Jibin Li Sid Bhoopathy Ismael J. Hidalgo |
author_facet |
Lisa Murray Antonio Arias Jibin Li Sid Bhoopathy Ismael J. Hidalgo |
author_sort |
Lisa Murray |
title |
Innovative in vitro methodologies for establishing therapeutic equivalence |
title_short |
Innovative in vitro methodologies for establishing therapeutic equivalence |
title_full |
Innovative in vitro methodologies for establishing therapeutic equivalence |
title_fullStr |
Innovative in vitro methodologies for establishing therapeutic equivalence |
title_full_unstemmed |
Innovative in vitro methodologies for establishing therapeutic equivalence |
title_sort |
innovative in vitro methodologies for establishing therapeutic equivalence |
publisher |
Pan American Health Organization |
url |
https://doaj.org/article/6024aa09fa994875886a575be0bf3991 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Revista Panamericana de Salud Pública, Vol 40, Iss 1, Pp 23-28 |
op_relation |
http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S1020-49892016000700023&lng=en&tlng=en https://doaj.org/toc/1680-5348 1680-5348 https://doaj.org/article/6024aa09fa994875886a575be0bf3991 |
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1766342361211731968 |