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Evaluation of the concordance of pharmacogenomic information in the RCM and FI with the international recommendations of CPIC and PharmGKB

2026-05-29Documento de conferência Acesso aberto
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dc.contributor.authorAlmeida, Nuno
dc.contributor.authorVasconcelos, Ana
dc.contributor.authorLacerda, Ivo
dc.contributor.authorSantos, Marlene
dc.contributor.authorSantos, Marlene
dc.date.accessioned2026-07-28T09:15:19Z
dc.date.available2026-07-28T09:15:19Z
dc.date.issued2026-05-29
dc.description.abstractPharmacogenomics plays an increas-ing role in optimizing antiviral therapy, allowing the choice and dosage of drugs to be tailored to the pa-tient’s genetic profile. However, the integration of this information into regulatory documents, such as the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL), remains inconsistent. To evaluate the degree of concordance between the pharmacogenomic information present-ed in the SmPC and PIL of antiviral drugs with the international recommendations of the Clinical Phar-macogenetics Implementation Consortium (CPIC) and the evidence levels reported in PharmGKB. An analysis was conducted on a set of 146 marketed antiviral drugs, assessing the presence of pharmacogenomic recommendations in their respec-tive SmPCs and PILs. These data were compared with CPIC guidelines and the pharmacogenomic evidence levels assigned by PharmGKB. Results: Only 14 out of the 146 drugs analysed pre-sented recommendations based on CPIC. Regarding PharmGKB evidence levels, most active substanc-es exhibited level 3. Complete agreement with CPIC guidelines was observed in only 2 SmPCs, while other 5 did not consider any genetic polymorphisms. The re-maining documents contained incomplete or partially aligned pharmacogenomic information relative to in-ternational recommendations. The results show that, with the excep-tion of abacavir, there is a discrepancy between the available pharmacogenomic evidence and its inte-gration into the SmPCs of antiviral medicines. This misalignment reinforces the need for more compre-hensive studies and effective harmonization between international guidelines and the content of SmPCs, promoting the adoption of personalized medicine.eng
dc.identifier.citationAlmeida, N., Vasconcelos, A., Lacerda, I., & Santos, M. (2026). Evaluation of the concordance of pharmacogenomic information in the RCM and FI with the international recommendations of CPIC and PharmGKB. Book of Abstracts of the 8th Meeting on Medicinal Biotechnology, 34. https://edicoes.ipp.pt/index.php/books/catalog/book/251
dc.identifier.doi10.26537/ed.p.porto.251
dc.identifier.isbn978-989-9226-20-3
dc.identifier.urihttp://hdl.handle.net/10400.22/32634
dc.language.isoeng
dc.peerreviewedyes
dc.publisherPolitema
dc.relation.hasversionhttps://edicoes.ipp.pt/index.php/books/catalog/book/251
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectPharmacogenomics
dc.subjectAntiviral
dc.subjectcpic
dc.subjectsmpcs
dc.subjectAbacavir
dc.subjectAtazanavir
dc.titleEvaluation of the concordance of pharmacogenomic information in the RCM and FI with the international recommendations of CPIC and PharmGKBeng
dc.typeconference object
dspace.entity.typePublication
oaire.citation.conferenceDate2026-05-29
oaire.citation.conferencePlacePorto
oaire.citation.endPage34
oaire.citation.startPage34
oaire.citation.titleBook of Abstracts of the 8th Meeting on Medicinal Biotechnology
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameSantos
person.givenNameMarlene
person.identifier1508370
person.identifier.ciencia-id8311-B967-31C4
person.identifier.orcid0000-0001-5020-5942
person.identifier.scopus-author-id57110502000
relation.isAuthorOfPublication8ce9ee39-a4c6-46ae-99e2-49397b550f1b
relation.isAuthorOfPublication.latestForDiscovery8ce9ee39-a4c6-46ae-99e2-49397b550f1b

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