Results 1 to 10 of about 471,343 (250)

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, Zhichao Liu, Leihong Wu, Minjun Chen, Weida Tong   +4 more
doaj   +2 more sources

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, Ping Ren, Yi Zhang, Xiajing Gong, Meng Hu, Hualou Liang   +5 more
doaj   +2 more sources

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
doaj   +2 more sources

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, Taylor Ingle, Zhichao Liu, Anna Zhao-Wong, Stephen Harris, Shraddha Thakkar, Guangxu Zhou, Junshuang Yang, Joshua Xu, Darshan Mehta, Weigong Ge, Weida Tong, Hong Fang   +12 more
doaj   +2 more sources

Drug Labeling and Exposure in Neonates [PDF]

JAMA Pediatrics, 2014
Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new pediatric information in product labeling. However, approximately 50% of drug labels still have insufficient information on safety, efficacy, or dosing in children. Neonatal information in labeling is even scarcer
Christoph P. Hornik, William J. Rodriguez, Matthew M. Laughon, Debbie Avant, Michael Cohen-Wolkowiez, P. Brian Smith, Nidhi Tripathi, Reese H. Clark   +7 more
openaire   +4 more sources

Labelling Drugs [PDF]

BMJ, 1966
C. D. Needham
  +7 more sources

Labelling of drugs. [PDF]

BMJ, 1970
H G Easton
openaire   +4 more sources

Enhancing pharmacogenomic data accessibility and drug safety with large language models: a case study with Llama3.1 [PDF]

Experimental Biology and Medicine
Pharmacogenomics (PGx) holds the promise of personalizing medical treatments based on individual genetic profiles, thereby enhancing drug efficacy and safety.
Dan Li, Leihong Wu, Ying-Chi Lin, Ying-Chi Lin, Ho-Yin Huang, Ho-Yin Huang, Ebony Cotton, Qi Liu, Ru Chen, Ruihao Huang, Yifan Zhang, Joshua Xu   +11 more
doaj   +2 more sources

Syringe drug labels [PDF]

Anaesthesia, 2000
J. P. JAYASURIYA
openaire   +3 more sources

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
doaj   +1 more source