BERT-Based Natural Language Processing of Drug Labeling Documents: A Case Study for Classifying Drug-Induced Liver Injury Risk [PDF]
Frontiers in Artificial Intelligence, 2021 Background & Aims: The United States Food and Drug Administration (FDA) regulates a broad range of consumer products, which account for about 25% of the United States market.
Yue Wu +4 more
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Information Extraction From FDA Drug Labeling to Enhance Product-Specific Guidance Assessment Using Natural Language Processing [PDF]
Frontiers in Research Metrics and Analytics, 2021 Towards the objectives of the UnitedStates Food and Drug Administration (FDA) generic drug science and research program, it is of vital importance in developing product-specific guidances (PSGs) with recommendations that can facilitate and guide generic ...
Yiwen Shi +5 more
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Drug labeling: The study of compliance of regulatory requirements for prescription drugs in India
Perspectives in Clinical Research, 2020 Objectives: The objective was to check the compliance of regulatory requirements of drug labeling in India according to guidelines given under the Drug and Cosmetic Rules (D & CRs) 1945, Section 96, 97; drug samples were collected from government drug ...
Suchi Shah, Anil Singh
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Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA [PDF]
BMC Bioinformatics, 2019 Background Adverse Drug Reactions (ADRs) are of great public health concern. FDA-approved drug labeling summarizes ADRs of a drug product mainly in three sections, i.e., Boxed Warning (BW), Warnings and Precautions (WP), and Adverse Reactions (AR), where
Leihong Wu +12 more
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Pediatric studies and labeling additions required by the U.S. FDA for novel drugs approved from 2011 to 2023: A retrospective cohort study. [PDF]
PLoS MedicineBackgroundThe U.S. Food and Drug Administration (FDA) has the authority to require that sponsors conduct pediatric studies for certain new drugs under the Pediatric Research Equity Act (PREA). Here, we evaluate the characteristics and completion of these
Rylee McGonigle +6 more
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Baclofen approval in france: A balance between two conceptions of medicine
European Psychiatry, 2021 In October 2018, France became the first country to officially approve baclofen for alcohol use disorder (AUD), even if the French Drug Agency (ANSM) officially stated that the efficacy of baclofen in AUD could be not established at this stage, in the ...
B. Rolland
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Labelling of stock preparations and extemporaneous drugs: National and international legislation and practices [PDF]
Arhiv za farmaciju, 2014 The pharmaceutical industry has provided drug production of uniform quality, safety and efficacy, and the same is necessary for the preparation of stock preparations and extemporaneous drugs.
Vuleta Gordana +2 more
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Neural text generation in regulatory medical writing
Frontiers in Pharmacology, 2023 Background: A steep increase in new drug applications has increased the overhead of writing technical documents such as medication guides. Natural language processing can contribute to reducing this burden.Objective: To generate medication guides from ...
Claudia Meyer +5 more
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Frontiers in Pharmacology, 2021 Introduction: Patient information leaflets (PILs) of medicinal products are informative documents that accompany medicines and explain their components, modes of use, interactions with other medicines, and other relevant issues.
Mariana Medina-Córdoba +3 more
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