A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions.

Autor: Gu T; Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center, Memphis, Tennesse, 38103, USA.; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, PR China., Wang G; General Surgery, The 2nd Hospital of Hebei Medical University, 215 Heping Road, Shijiazhuang, Hebei, China., van den Oord EJC; Center for Biomarker Research and Precision Medicine (BPM), Virginia Commonwealth University, VCU Health Sciences Research Building, Room 216A, P. O. Box 980533, Richmond, Virgina, 23298-0581, USA., Goldman E; Department of Microbiology, Biochemistry and Molecular Genetics, New Jersey Medical School, Rutgers University, Newark, New Jersey, 07103, USA., Yang C; Department of Orthopedic Surgery and BME-Campbell Clinic, University of Tennessee Health Science Centre, Memphis, Tennesse, 38163, USA., Xie N; College of Business, University of Louisville, Louisville, Kentucky, 40292, USA., Yao L; Department of Orthopedic Surgery and BME-Campbell Clinic, University of Tennessee Health Science Centre, Memphis, Tennesse, 38163, USA.; College of Health Management, Harbin Medical University, 157 Baojian Road, Harbin, 150081, Heilongjiang, China., Wang CY; The Centre for Biomedical Research, Department of Respiratory and Critical Care Medicine, NHC Key Laboratory of Respiratory Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China., Jablonski M; Department of Ophthalmology, University of Tennessee Health Sciences Center, Memphis, Tennesse, USA.; Department of Medicine, University of Tennessee Health Sciences Center, Memphis, Tennesse, USA.; Hamilton Eye Institute, University of Tennessee Health Sciences Center, Memphis, Tennesse, USA.; College of Nursing, University of Tennessee Health Science Center, Memphis, Tennesse, 38105, USA., Ray K; School of Biological Science, Ramkrishna Mission Vivekananda Education & Research Institute, Narendrapur, 700103, West Bengal, India., Liu F; Research Center, The Fourth Hospital of Hebei Medical University, 12 Jiankang Road, Shijiazhuang, 050011, China., Pan W; Respiratory Medicine and Intensive Care, The 2, Hospital of Hebei Medical University, 215 Heping Road, Shijiazhuang, Hebei, China., Flores G; Instituto de Fisiología, Benemérita Universidad Autónoma de Puebla, 14 Sur 6301, San Manuel, 72570, Puebla, Mexico., Aleya L; Chrono-Environnement Laboratory, UMR CNRS 6249, Bourgogne Franche-Comté University, 25030, Besançon Cedex, France., Meng X; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, PR China., Jiao Y; Department of Orthopedic Surgery and BME-Campbell Clinic, University of Tennessee Health Science Centre, Memphis, Tennesse, 38163, USA., Li M; Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center, Memphis, Tennesse, 38103, USA. mli54@uthsc.edu.; Memphis, USA. mli54@uthsc.edu., Wang Y; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, PR China. Yongjunwang1962@gmail.com.; Department of Neurology and Department of Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, No.119 South Fourth Ring West Road, Fengtai District, Beijing, 100070, China. Yongjunwang1962@gmail.com., Gu W; Department of Orthopedic Surgery and BME-Campbell Clinic, University of Tennessee Health Science Centre, Memphis, Tennesse, 38163, USA. wgu@uthsc.edu.; Lt. Col. Luke Weathers, Jr. VA Medical Center, 116 N Pauline St., Memphis, Tennesse, 38105, USA. wgu@uthsc.edu.; Department of Pharmaceutical Sciences, University of Tennessee Health Science Center, 956 Court Avenue, Memphis, Tennesse, 38163, USA. wgu@uthsc.edu.

Publikováno v: The AAPS journal [AAPS J] 2024 Aug 20; Vol. 26 (5), pp. 95. Date of Electronic Publication: 2024 Aug 20.

A framework enabling LLMs into regulatory environment for transparency and trustworthiness and its application to drug labeling document.

Autor: Wu L; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US FDA, 3900 NCTR Rd, Jefferson AR, 72211, USA. Electronic address: Leihong.wu@fda.hhs.gov., Xu J; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US FDA, 3900 NCTR Rd, Jefferson AR, 72211, USA., Thakkar S; Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), US FDA, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Gray M; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US FDA, 3900 NCTR Rd, Jefferson AR, 72211, USA., Qu Y; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US FDA, 3900 NCTR Rd, Jefferson AR, 72211, USA., Li D; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US FDA, 3900 NCTR Rd, Jefferson AR, 72211, USA., Tong W; Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, US FDA, 3900 NCTR Rd, Jefferson AR, 72211, USA. Electronic address: Weida.tong@fda.hhs.gov.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105613. Date of Electronic Publication: 2024 Apr 02.

Cardiovascular Drug Labeling: Do They Have Information on Necessary Precautions for Older People?

Autor: Lucas Oliveira Marques, Roberta Coutinho Vasconcelos, André Oliveira Baldoni, Ana Cristina Nogueira Rodrigues Pestana, Farah Maria Drumond Chequer

Publikováno v: Geriatrics, Gerontology and Aging, Vol 14, Pp 196-202 (2024)

OBJECTIVE: To analyze the existence of information on drug labeling intended for health professionals on the precaution of cardiovascular drugs use in older people. METHODS: This is a documentary study, carried out with the analysis of data contained

Externí odkaz: https://doaj.org/article/15531d34d4ee4233970bc045160dbfaa

Fine-tuning BERT for automatic ADME semantic labeling in FDA drug labeling to enhance product-specific guidance assessment.

Autor: Shi Y; College of Computing and Informatics, Drexel University, Philadelphia, PA, United States., Wang J; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Ren P; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., ValizadehAslani T; Department of Electrical and Computer Engineering, College of Engineering, Drexel University, Philadelphia, PA, United States., Zhang Y; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Hu M; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States., Liang H; School of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, PA, United States. Electronic address: hualou.liang@drexel.edu.

Publikováno v: Journal of biomedical informatics [J Biomed Inform] 2023 Feb; Vol. 138, pp. 104285. Date of Electronic Publication: 2023 Jan 09.

Drug labeling: The study of compliance of regulatory requirements for prescription drugs in India.

Autor: Shah, Suchi¹ (AUTHOR), Singh, Anil² (AUTHOR)

Publikováno v: Perspectives in Clinical Research. Oct-Dec2020, Vol. 11 Issue 4, p164-167. 4p.