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Full-Text Articles in Pharmacy Administration, Policy and Regulation
Employing “Fdalabel” Database To Extract Pharmacogenomics Information From Fda Drug Labeling To Advance The Study Of Precision Medicine, Ryley B. Uber, Hong Fang, Zhichao Liu, Joshua Xu, Shraddha Thakkar, Shashi Amur, Padmaja Mummaneni, Minjun Chen, Baitang Ning, Steve Harris, Guangxu Zhou, Leihong Wu, Paul Howard, Weida Tong
Employing “Fdalabel” Database To Extract Pharmacogenomics Information From Fda Drug Labeling To Advance The Study Of Precision Medicine, Ryley B. Uber, Hong Fang, Zhichao Liu, Joshua Xu, Shraddha Thakkar, Shashi Amur, Padmaja Mummaneni, Minjun Chen, Baitang Ning, Steve Harris, Guangxu Zhou, Leihong Wu, Paul Howard, Weida Tong
The Research and Scholarship Symposium (2013-2019)
Pharmacogenomics (PGx) focuses on how genomics and genetic variants (inherited and acquired) affect drug response. A better understanding of the association between genetic markers and individual phenotypes may improve therapy by enhancing drug efficacy, safety, and advance precision medicine. The FDALabel database (https://rm2.scinet.fda.gov/druglabel/#simsearch-0) was developed from the FDA's Structured Product Labeling (SPL) repository to allow users to perform full-text and customizable searches of the labeling section {e.g. Boxed Warning, Warning and Precautions, Adverse Reaction (AR) sections}. In this study, 48 known biomarkers were used to query PGx relevant contents from the FDALabel database, including Indication, Clinical Pharmacology, Clinical Studies, and …