Establishment of Drug Risk Management System -the Promise of Safety Science Approaching from Non-Clinical Safety

Tsunenari, Ichiro; BARATA, Kyoko; Nakayama, Naoki; Sugai, Shoichiro; Tan, Motomu; Shoji, Shuichi; UNNO, Takashi; Matsumoto, Kazuhiko

doi:10.3820/jjpe.13.29

Cited by 1 publication

(1 citation statement)

References 1 publication

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Since the ultimate goal of drug risk management is the appropriate and safe use of drugs, data mining is regularly used to detect such positive reactions. 1 However, there is no method for identifying the risk factors of rare adverse drug reactions (ADRs). Moreover, hospitals and pharmacies cannot afford to avoid the prescription of all primary drugs suspected of ADRs.…”

Section: Introductionmentioning

confidence: 99%

A Practical Estimation Method for Analyzing Adverse Drug Reactions Using Data Mining

Shirakuni

Okamoto

Uejima

et al. 2013

Ther Innov Regul Sci

View full text Add to dashboard Cite

This study aimed to determine the potentially severe chemical properties of drugs that can cause adverse drug reactions (ADRs) such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) by using a data mining method. The study data were extracted from the Adverse Event Reporting System database of the FDA. EM was considered a mild reaction, and SJS and TEN were considered severe reactions. In this study, a new concept termed the "risk of aggravation" (ROA) was defined as whether a certain drug is more likely to cause severe adverse reactions than mild ones. Partial least squares and logistic regression analysis were applied using binary response variable ROAs. These analyses correctly predicted 50 of the 72 drugs associated with SJS and/or TEN and 28 of the 38 drugs associated with EM using binary chemical descriptors that are the same as those using the metric chemical descriptors.

show abstract

Section: Introductionmentioning

confidence: 99%