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Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view.


ABSTRACT: Pharmacogenomic biomarker availability of Hungarian Summaries of Product Characteristics (SmPC) was assembled and compared with the information in US Food and Drug Administration (FDA) drug labels of the same active substance (July 2019). The level of action of these biomarkers was assessed from The Pharmacogenomics Knowledgebase database. From the identified 264 FDA approved drugs with pharmacogenomic biomarkers in drug label, 195 are available in Hungary. From them, 165 drugs include pharmacogenomic data disposing 222 biomarkers. Most of them are metabolizing enzymes (46%) and pharmacological targets (41%). The most frequent therapeutic area is oncology (37%), followed by infectious diseases (12%) and psychiatry (9%) (p?

SUBMITTER: Varnai R 

PROVIDER: S-EPMC7253355 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view.

Varnai Reka R   Szabo Istvan I   Tarlos Greta G   Szentpeteri Laszlo Jozsef LJ   Sik Attila A   Balogh Sandor S   Sipeky Csilla C  

The pharmacogenomics journal 20191202 3


Pharmacogenomic biomarker availability of Hungarian Summaries of Product Characteristics (SmPC) was assembled and compared with the information in US Food and Drug Administration (FDA) drug labels of the same active substance (July 2019). The level of action of these biomarkers was assessed from The Pharmacogenomics Knowledgebase database. From the identified 264 FDA approved drugs with pharmacogenomic biomarkers in drug label, 195 are available in Hungary. From them, 165 drugs include pharmacog  ...[more]

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