Health regulatory communications of well-established safety-related pharmacogenomics associations in six developed countries: an evaluation of alignment View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-03

AUTHORS

W C Tan-Koi, Evelyn S H Lim, Y Y Teo

ABSTRACT

Recommendations on genetic testing are typically conveyed by drug regulatory authorities through drug labels, which are legal requirements for market authorization of drugs. We conducted a cross-sectional study of drug labels focusing on three crucial aspects of regulatory pharmacogenomics communications: (i) intent; (ii) interpretation in the local context; and (iii) implications of the genetic information. Labels of drugs associated with well-established safety-related genetic markers for adverse drug reactions across six developed countries of United States, Canada, United Kingdom, Australia, New Zealand and Singapore were reviewed. We found differing medical advice for genotype-positive HLA-B*15:02, HLA-A*31:01, UGT1A1*28 and CYP2D6 ultra-rapid metabolisers in breastfeeding women. This raises questions on implications to clinical practice between these countries. Varying ways of presenting at-risk population and allele frequencies also raises question in incorporating such information in drug labels. An international guidance addressing these crucial aspects of regulatory pharmacogenomic communications in drug labels is long overdue. More... »

PAGES

121-127

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/tpj.2016.5

DOI

http://dx.doi.org/10.1038/tpj.2016.5

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1036900446

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26902540


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N-Triples is a line-based linked data format ideal for batch operations.

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Turtle is a human-readable linked data format.

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RDF/XML is a standard XML format for linked data.

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This table displays all metadata directly associated to this object as RDF triples.

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