Results 31 to 40 of about 588,781 (167)

Impact of body mass index on the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus: A subgroup analysis of 3‐month interim results from the Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use study

Journal of Diabetes Investigation, 2019
Aims/Introduction Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use is an ongoing postmarketing study of ipragliflozin for long‐term use in Japanese patients with type 2 diabetes mellitus.
Kazuyuki Tobe, Hiroshi Maegawa, Hiromi Tabuchi, Ichiro Nakamura, Satoshi Uno   +4 more
doaj   +1 more source

Nonmelanoma Skin Cancer Risk With JAK Inhibitors Compared to Interleukin‐6 Receptor Inhibitors in Rheumatoid Arthritis: Results From a National Cohort Study

Arthritis &Rheumatology, EarlyView.
Objective Nonmelanoma skin cancer (NMSC) is one of the most common malignancies in rheumatoid arthritis (RA). This analysis assessed NMSC risk with JAK inhibitors (JAKi) compared to interleukin‐6 receptor inhibitors (IL‐6Ri). Methods This study used data from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis linked to the
Zixing Tian, Lianne Kearsley‐Fleet, Sizheng Steven Zhao, James Galloway, Mark Lunt, Kath Watson, Narges Azadbakht, British Society for Rheumatology Biologics Register in Rheumatoid Arthritis Contributors Group, Kimme L. Hyrich   +8 more
wiley   +1 more source

Risk of Cancer According to Duration of Targeted Therapy Exposure in Spondyloarthritis: A Nationwide Cohort Study From the French Health Insurance Database

Arthritis &Rheumatology, EarlyView.
Objective To assess the association between duration of targeted therapy exposure and cancer risk in patients with spondyloarthritis (SpA), including those with psoriatic arthritis, axial SpA, and other subtypes. Methods This nationwide cohort study used the French health insurance database to identify adults with SpA initiating a targeted therapy ...
Karine Tankovic, Pascal Claudepierre, Tat Thang Vo, Tran Trong Khoi Le, Siham Iggui, Laetitia Penso, Emilie Sbidian, Laura Pina Vegas   +7 more
wiley   +1 more source

Systematic postmarketing surveillance needed for misused psychoactive pharmaceutical drugs

, 2023
Systematic postmarketing surveillance needed for misused psychoactive pharmaceutical ...
Tracy W Soh (13465329)
core  

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting

Clinical Pharmacology &Therapeutics, EarlyView.
Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, but the extent to which these suffixes have been incorporated into ...
Danijela Stojanovic, Lisa Wolf, M. Stacey Ricci, Monica A. Muñoz   +3 more
wiley   +1 more source

Characteristics of “Hard-to-Use” Press-Through-Package Sheets: An Analysis of Information Collected by Marketing Specialists of a Japanese Medical Wholesaler

Patient Preference and Adherence, 2020
Kenji Kabeya,1 Hiroki Satoh,2,3 Satoko Hori,4 Yasumasa Miura,5 Yasufumi Sawada2 1Faculty of Pharmaceutical Sciences, The University of Tokyo, Tokyo 113-0033, Japan; 2Laboratory of Drug Lifetime Management, Graduate School of Pharmaceutical Sciences, The ...
Kabeya K, Satoh H, Hori S, Miura Y, Sawada Y   +4 more
doaj  

A Practical Guide to Implementing Real‐World Evidence as Primary Basis for Approval and Label Expansion

Clinical Pharmacology &Therapeutics, EarlyView.
In June 2026, the FDA issued a revised draft guidance describing the circumstances in which one adequate and well‐controlled clinical investigation plus confirmatory evidence may satisfy the statutory substantial evidence standard for establishing efficacy and safety. Confirmatory evidence includes real‐world evidence (RWE).
Tracy J. Mayne, Maurice A. Brookhart, Nancy A. Dreyer   +2 more
wiley   +1 more source

Digital Therapeutics in Perspective: From Regulatory Challenges to Post-Marketing Surveillance

Frontiers in Drug Safety and Regulation, 2022
Digital therapeutics (DTx) are innovative therapeutic interventions, in which the therapeutic activity is carried out by algorithms and software. They represent a new opportunity especially for the treatment of chronic pathologies associated with ...
Salvatore Crisafulli, Eugenio Santoro, Giuseppe Recchia, Giuseppe Recchia, Gianluca Trifirò   +4 more
doaj   +1 more source

Multi‐omics–driven precision medicine

iMeta, EarlyView.
Multi‐omics‐driven precision medicine (MODPM) provides a multiscale, continuously learnable framework that integrates genomics, epigenomics, transcriptomics, proteomics, metabolomics, microbiome profiles, and clinical data. Powered by artificial intelligence and foundation models, MODPM enables cross‐modal representation learning, contextual modeling ...
Huibo Li, Zhe Zhao, Yifan Zhang, Yao Ma, Gaofei Hu, Min Zeng, Zhanqun Yang, Zixuan Zhao, Xin Zhou, Wei Hu, Yuxuan Sun, Meng Su, Jun Li, Matthew Whiteman, Wei Fu, Chao Zhong, Lemin Zheng, Long Chen, Hairong Lv, Rongsheng Zhao, Yi Zhun Zhu   +20 more
wiley   +1 more source