Study of pharmacogenomic information in FDA-approved drug labeling to facilitate application of precision medicine

被引：24

作者：

Mehta, Darshan ^{[1
]}

Uber, Ryley ^{[2
,5
]}

Ingle, Taylor ^{[1
]}

Li, Catherine ^{[3
]}

Liu, Zhichao ^{[1
]}

Thakkar, Shraddha ^{[1
]}

Ning, Baitang ^{[1
]}

Wu, Leihong ^{[1
]}

Yang, Junshuang ^{[1
]}

Harris, Steve ^{[1
]}

Zhou, Guangxu ^{[1
]}

Xu, Joshua ^{[1
]}

Tong, Weida ^{[1
]}

Lesko, Lawrence ^{[4
]}

Fang, Hong ^{[1
]}

机构：

[1] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA

[2] Univ Pittsburg, Dept Pharm & Therapeut, Pittsburgh, PA 15213 USA

[3] US FDA, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[4] Univ Florida, Coll Pharm, Orlando, FL 32827 USA

[5] US FDA, Oak Ridge Inst Sci & Educ, Res Participat Program, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA

来源：

DRUG DISCOVERY TODAY | 2020年 / 25卷 / 05期

关键词：

IMPLEMENTATION CONSORTIUM; BIOMARKERS; THERAPY;

D O I：

10.1016/j.drudis.2020.01.023

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Pharmacogenomics (PGx), studying the relationship between drug response and genetic makeup of an individual, is accelerating advances in precision medicine. The FDA includes PGx information in the labeling of approved drugs to better inform on their safety and effectiveness. We herein present a summary of PGx information found in 261 prescription drug labeling documents by querying the publicly available FDALabel database. A total of 362 drug-biomarker pairs (DBPs) were identified. We profiled DBPs using frequency of the biomarkers and their therapeutic classes. Four categories of applications (indication, safety, dosing and information) were discussed according to information in labeling. This analysis facilitates better understanding, utilization and translation of PGx information in drug labeling among researchers, healthcare professionals and the public.

引用

页码：813 / 820

页数：8

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