Results 31 to 40 of about 10,049 (144)

The landscape of Phase IV Clinical Trials in India – A comprehensive analysis of the Clinical Trial Registry-India

Perspectives in Clinical Research
Purpose: Phase IV clinical studies are usually performed after a new drug obtains approval from a regulatory agency for marketing and use in the general population.
Bikash Ranjan Meher, Bikram Keshari Rout, Subashri Ponnusamy, Rashmi Ranjan Mohanty, Biswa Mohan Padhy   +4 more
doaj   +1 more source

Evidence at time of regulatory approval and cost of new antibiotics in 2016-19: cohort study of FDA approved drugs

BMJ Medicine, 2022
Objective To review the clinical evidence, regulatory background, and cost of antibiotics approved by the US Food and Drug Administration (FDA), 2016-19.Design Cohort study of FDA approved drugs.Data sources FDA databases, ClinicalTrials.gov, and drug ...
Aaron S Kesselheim, John H Powers, Mayookha Mitra-Majumdar, Beatrice L Brown   +3 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

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

Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post‐authorization studies, 2022–2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu, William A. Blumentals, Froilan G. Celzo, G. Caleb Alexander, Lingyun Zhou, Juhaeri Juhaeri, Corinne Jouquelet‐Royer, Jian‐Yu E   +7 more
wiley   +1 more source

Denosumab for the treatment of osteoporosis

Osteoporosis and Sarcopenia, 2017
Denosumab, a specific inhibitor of RANK ligand, is a novel therapy for postmenopausal osteoporosis and related disorders. An extensive clinical development program has evaluated the clinical efficacy and safety of denosumab with several thousand patients
Michael R. McClung
doaj   +1 more source

Alemtuzumab-induced alopecia universalis and transient accommodation spasm in a patient with multiple sclerosis

Therapeutic Advances in Neurological Disorders, 2022
Herein, we report a case of alopecia universalis and transient accommodation spasm presented after alemtuzumab administration in a patient previously treated with fingolimod.
Dimitrios Tzanetakos, Marianthi Breza, John S. Tzartos, Georgios Bontzos, Aigli G. Vakrakou, Alexandros Dermentzoglou, Ilias Gkizis, Georgios Smoustopoulos, Maria-Eleptheria Evangelopoulos, Leonidas Stefanis, Costantinos Kilidireas   +10 more
doaj   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Depression Events Associated with Proton-Pump Inhibitors in Postmarketing Drug Surveillance Data

Pharmacoepidemiology, 2023
Proton-pump inhibitors, PPIs, are widely prescribed and are available over the counter for prolonged reduction of stomach acid production and related disorders. PPIs irreversibly inhibit the hydrogen/potassium ATPase in gastric parietal cells.
Tigran Makunts, Haroutyun Joulfayan, Kenneth Ta, Ruben Abagyan   +3 more
doaj   +1 more source