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https://www.um.edu.mt/library/oar/handle/123456789/48536| Title: | Pharmacogenomics information in official drug labelling |
| Authors: | Azzopardi, Yasmine Wirth, Francesca Camilleri, Liberato Serracino-Inglott, Anthony Azzopardi, Lilian M. |
| Keywords: | Pharmacogenomics -- Research Drugs -- Labeling United States. Food and Drug Administration European Agency for the Evaluation of Medicinal Products |
| Issue Date: | 2019-09 |
| Publisher: | University of Malta. Department of Pharmacy |
| Citation: | Azzopardi, Y., Wirth, F., Camilleri, L., Serracino-Inglott, A., & Azzopardi, L. M. (2019, September). Pharmacogenomics information in official drug labelling. Poster session presented at the 79th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2019, Abu Dhabi, United Arab Emirates. |
| Abstract: | A poster presentation regarding pharmacogenomics information in official drug labelling. Introduction: The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are continually updating drug labels and Summary of Product Characteristic s (SmPC) with pharmacogenomic (PGx) information. Harmonisation of PGx information in drug labelling between regulatory bodies facilitates clinical implementation of PGx. Aims: ● To compare PGx information in official drug labelling between the US FDA and the EMA: Inclusion of PGx information within headings and sub-headings of drug labels and SmPCs ● Quality of PGx information in drug labels and SmPCs. |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/48536 |
| Appears in Collections: | Scholarly Works - FacM&SPha Scholarly Works - FacSciSOR |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| Pharmacogenomics_information_in_official_drug_labelling_2019.pdf | 269.4 kB | Adobe PDF | View/Open |
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