Modeling and Simulations in Latin-American Generic Markets: Perspectives from Chilean Local Industry, Regulatory Agency, and Academia

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dc.catalogadorvzp
dc.contributor.authorGarcia, Mauricio A.
dc.contributor.authorPaulos, Claudio
dc.contributor.authorVinales, Manuel Ibarra
dc.contributor.authorMichelet, Robin
dc.contributor.authorCabrera-Pérez, Miguel Ángel
dc.contributor.authorAceituno, Alexis
dc.contributor.authorBone, Michelle
dc.contributor.authorIbacache Figueroa, Mauricio Enrique
dc.contributor.authorCortínez Fernández, Luis Ignacio
dc.contributor.authorGuzman, Marcelo
dc.date.accessioned2024-12-31T13:19:49Z
dc.date.available2024-12-31T13:19:49Z
dc.date.issued2024
dc.description.abstractIn the last 20 years, modeling and simulations (M&S) have gained increased attention in pharmaceutical sciences. International industry and world-reference agencies have used M&S to make cost-efficient decisions through the model-informed drug development (MIDD) framework. Modeling tools include biopredictive dissolution models, physiologically based pharmacokinetic models (PBPK), biopharmaceutic models (PBBM), and virtual bioequivalence, among many others. Regulatorily, health agencies are becoming more and more open to accept the use of M&S to support regulatory applications, including setting dissolution specifications, quality-by-design (QbD), postapproval changes (SUPAC), etc. Nonetheless, the potential of M&S has been only barely explored in Latin America (Latam) across different actors: industry, regulatory agencies, and even academia. In this manuscript, we discuss the challenges and opportunities for implementing M&S approaches in Latam. Perspectives of regional experts were shared in a workshop. Attendance (professionals from industry, regulator, academia, and clinicians) also shared their views via survey. The rational development of bioequivalent generics was considered the main opportunity for M&S in regional market, particularly the use of PBPK and PBBM. Nonetheless, a critical mass of modeling scientists is needed before Latin American industry and regulators can actually benefit from M&S. Collaborations (e.g., Academia-Industry and Academia-Regulatory) may be a path to develop applied research projects and train the future modelers. Reaching that critical mass, scientists from industry may apply modeling across generic drug development process and life cycle, while regulatory scientists may issue guidelines in local language to support regional industry. Only at that stage could the full potential of MIDD be reached in Latin American generic markets.
dc.format.extent9 páginas
dc.fuente.origenWOS
dc.identifier.doi10.1021/acs.molpharmaceut.4c00764
dc.identifier.eissn1543-8392
dc.identifier.eissn1543-8392
dc.identifier.issn1543-8384
dc.identifier.urihttps://doi.org/10.1021/acs.molpharmaceut.4c00764
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/89409
dc.identifier.wosidWOS:001343790200001
dc.information.autorucEscuela de Medicina; Ibacache Figueroa Mauricio Enrique; S/I; 817
dc.information.autorucEscuela de Medicina; Cortinez Fernandez Luis Ignacio; 0000-0001-8544-8768; 79356
dc.issue.numero12
dc.language.isoen
dc.nota.accesocontenido parcial
dc.pagina.final6108
dc.pagina.inicio6100
dc.publisherAMER CHEMICAL SOC
dc.revistaMolecular Pharmaceutics
dc.rightsacceso restringido
dc.subjectLatin America
dc.subjectGeneric drug products
dc.subjectModelingand simulations
dc.subjectMIDD
dc.subjectPBBM
dc.subjectVirtual bioequivalence
dc.subjectPharmacometrics
dc.subject.ods03 Good health and well-being
dc.subject.odspa03 Salud y bienestar
dc.titleModeling and Simulations in Latin-American Generic Markets: Perspectives from Chilean Local Industry, Regulatory Agency, and Academia
dc.typeartículo
dc.volumen21
sipa.codpersvinculados817
sipa.codpersvinculados79356
sipa.trazabilidadWOS;2024-11-09
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