ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

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dc.contributor.authorMiranda, Claudia
dc.contributor.authorAceituno, Alexis
dc.contributor.authorFernández, Mirna
dc.contributor.authorMendes, Gustavo
dc.contributor.authorRodríguez, Yanina
dc.contributor.authorLlauró, Verónica
dc.contributor.authorCabrera-Pérez, Miguel Ángel
dc.date.accessioned2022-11-30T02:46:36Z
dc.date.available2022-11-30T02:46:36Z
dc.date.issued2021
dc.description.abstractThe biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.en_ES
dc.facultadFacultad de Farmaciaen_ES
dc.file.nameMiranda_Ich2021.pdf
dc.identifier.citationMiranda, C.; Aceituno, A.; Fernández, M.; Mendes, G.; Rodríguez, Y.; Llauró, V.; Cabrera-Pérez, M.Á. ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries. Pharmaceutics 2021, 13, 363. https://doi.org/10.3390/pharmaceutics13030363en_ES
dc.identifier.doihttps://doi.org/10.3390/pharmaceutics13030363
dc.identifier.urihttp://repositoriobibliotecas.uv.cl/handle/uvscl/7432
dc.languageen
dc.publisherMDPI
dc.rightsThis is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
dc.sourcePharmaceutics
dc.subjectBIOEQUIVALENCEen_ES
dc.subjectBIOWAIVERen_ES
dc.subjectDISSOLUTIONen_ES
dc.subjectBCSen_ES
dc.subjectLATIN AMERICAen_ES
dc.subjectMULTISOURCE DRUGen_ES
dc.titleICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries
dc.typeArticulo

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