Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays

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dc.contributor.authorMiranda-Pérez De Alejo, Claudia
dc.contributor.authorAceituno Álvarez, Alexis
dc.contributor.authorMendes Lima Santos, Gustavo
dc.contributor.authorFernández Cervera, Mirna
dc.contributor.authorJung-Cook, Helgi
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 replacement of traditional in vivo bioequivalence studies by in vitro dissolution assays, based on the biopharmaceutical classification system (BCS), has emerged as an important tool for demonstrating the interchangeability of multisource products. This paper summarizes the current implementation of the BCS-based biowaiver for the development of multisource products in Latin America, and identifies several challenges and opportunities for greater convergence and application of BCS regulatory requirements. Methods. Differences and similarities between the current BCS-based biowaivers’ guidelines proposed by two relevant regulatory agencies for the Latin American region (FDA and WHO) and the new ICH harmonization guideline were identified and compared. An update of the BCS-based biowaiver guideline for Latin American countries was also considered, based on the respective regulatory information on bioequivalence studies, which is publicly available. Results. About 50% of the Latin American countries analyzed have no information on the implementation of any bioequivalence standards, while in the countries where bioequivalence studies are considered, the acceptance and application of BCS-based biowaiver requirements is quite heterogeneous. This situation contrasts with the international trend of global harmonization for BCS-based biowaiver guidance, suggesting the need in Latin America to identify opportunities and overcome challenges to improve the development of BCS-based biowaivers to avoid costly and time-consuming in vivo bioequivalence studies. Conclusions.The study shows that the region is in a position to improve access to safe and effective medicines at a reasonable cost by applying BCS-based biowaiver guidance.en_ES
dc.facultadFacultad de Farmaciaen_ES
dc.file.nameMiranda_Pol2021.pdf
dc.identifier.citationMiranda-Pérez de Alejo, C., Aceituno Álvarez, A., Mendes Lima Santos, G. et al. Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays. Ther Innov Regul Sci 55, 65–81 (2021). https://doi.org/10.1007/s43441-020-00191-7en_ES
dc.identifier.doihttps://doi.org/10.1007/s43441-020-00191-7
dc.identifier.urihttp://repositoriobibliotecas.uv.cl/handle/uvscl/7433
dc.languageen
dc.publisherSpringer
dc.sourceTherapeutic Innovation & Regulatory Science
dc.subjectBIOEQUIVALENCEen_ES
dc.subjectLATIN AMERICAen_ES
dc.subjectDISSOLUTIONen_ES
dc.subjectBIOWAIVERen_ES
dc.subjectBCSen_ES
dc.subjectGENERIC DRUGSen_ES
dc.subjectDRUG REGULATIONSen_ES
dc.titlePolicy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays
dc.typeArticulo
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