Pharmacogenomic biomarker information on drug labels of the Spanish Agency of Medicines and Sanitary products: evaluation and comparison with other regulatory agencies
Author:
Funder
Ministry of Economy and Competitiveness | Instituto de Salud Carlos III
Agencia Española de Medicamentos y Productos Sanitarios
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology,Genetics,Molecular Medicine
Link
https://www.nature.com/articles/s41397-023-00321-y.pdf
Reference40 articles.
1. Schuck RN, Grillo JA. Pharmacogenomic biomarkers: An FDA perspective on utilization in biological product labeling. AAPS J. 2016;18:573–7.
2. Haga SB, Mills R, Moaddeb J. Pharmacogenetic information for patients on drug labels. Pharmgenomics Pers Med. 2014;7:297–305.
3. Lauschke VM, Ingelman-Sundberg M. How to consider rare genetic variants in personalized drug therapy. Clin Pharm Ther. 2018;103:745–8.
4. Lam YWF. Scientific challenges and implementation barriers to translation of pharmacogenomics in clinical practice. Omics Clin Pract: Genom Pharmacogenomics Proteom Transcriptom Clin Res. 2014;2013:95–133.
5. Relling MV, Evans WE. Pharmacogenomics in the clinic. Nature. 2015;526:343–50.
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