«product labelling»
۲۳٬۷۰۲ نتیجهDynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness
Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfo
Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study.
BACKGROUND Because vital details of potential pharmacokinetic drug-drug interactions are often described in free-text structured product labels, manual curation is a necessary but expensive step in the development of electronic drug-drug interaction information resources. The use
Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force.
BACKGROUND Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label. OBJECTIVE The purpose of the current task force report is to recommend good
ISPOR TASK FORCE REPORTS Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force
Background: Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label. Objective: The purpose of the current task force report is to recommend go
Clinically relevant safety issues associated with St. John's wort product labels
BACKGROUND St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of
Profiling structured product labeling with NDF-RT and RxNorm
UNLABELLED BACKGROUND Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by United States Food and Drug Administration (FDA) as a mechanism for exchanging drug product information. The SPL drug labels contain rich info
Title: A Supervised Machine Learning Framework for the Extraction of Drug-Drug Interactions from Structured Product Labels Authors and affiliations:
Background: Information about drug-drug interactions (DDIs) is found in the medical literature and in drug package inserts published on DailyMed in addition to commercial drug databases. Objectives: To develop a machine learning framework for the extraction of DDIs from structure
Automatic Classification of Structured Product Labels for Pregnancy Risk Drug Categories, a Machine Learning Approach
With regular expressions and manual review, 18,342 FDA-approved drug product labels were processed to determine if the five standard pregnancy drug risk categories were mentioned in the label. After excluding 81 drugs with multiple-risk categories, 83% of the labels had a risk ca
Survey among agricultural workers about interpretation of plant protection product labels and safety data sheets.
The objective of this work was to examine the effectiveness of risk communication in agriculture through examination and interpretation of safety data sheets and product labels for agriculture products classified as hazardous. Labels and safety data sheets were shown to the users
Structured Product Labeling Improves Detection of Drug-Intolerance Issues
OBJECTIVES This study sought to assess the value of the Health Level 7/U.S. Food and Drug Administration Structured Product Labeling (SPL) drug knowledge representation standard and its associated terminology sources for drug-intolerance (allergy) decision support in computerized