Results 11 to 20 of about 6,029 (168)

Evolving Real-World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan-An Analysis of the 6-Year Trend. [PDF]

Clin Pharmacol Ther
Several regulatory initiatives have been made to clarify the acceptability and requirements of real‐world data and real‐world evidence (RWD/E) for the benefit/risk assessment of new medical products in Japan. The objectives of this review were to characterize the use of RWD/E in regulatory applications of new medical products and to describe the ...
Okami S, Shimotsumagari K, Sadatsuki Y.
europepmc   +2 more sources

Real-World Outcomes of Avelumab Maintenance Therapy in Patients With Curatively Unresectable Urothelial Carcinoma in Japan: Results From the Final Analysis of Postmarketing Surveillance. [PDF]

Cancer Med
ABSTRACT Background Avelumab maintenance therapy was approved in Japan in February 2021 for the treatment of curatively unresectable urothelial carcinoma (UC) that has not progressed after prior chemotherapy based on results from the JAVELIN Bladder 100 phase 3 trial.
Kikuchi E, Nagata M, Ito T, Sato M, Ogi M, Morita M, Kajita M, Nishiyama H.   +7 more
europepmc   +2 more sources

Identifying Pediatric Drug Safety Knowledge Gaps: An Integrated Approach Leveraging Real-World Data, a Biomedical Knowledge Base, and Postmarketing Surveillance Data. [PDF]

Pharmacotherapy
ABSTRACT Background Drug safety has historically been understudied in pediatric populations, rendering them “therapeutic orphans.” Pediatric drug indications and dosages are often inferred by extrapolating safety, efficacy, and dosing data from adult studies, leading to widespread off‐label use.
Rahurkar S, Ouyang J, Jonnalagadda P, Liu X, Zhang S, Chiang CW, Wang L, Shendre A, Li L.   +8 more
europepmc   +2 more sources

Monthly buprenorphine depot injection (SUBLOCADE®) for opioid use disorder during pregnancy. [PDF]

Am J Addict
Abstract Background and Objectives Untreated opioid use disorder (OUD) in pregnancy is associated with adverse obstetrical outcomes, maternal morbidity, and maternal mortality. This article will inform clinicians about the use of monthly extended‐release buprenorphine (BUP‐XR, SUBLOCADE®) to treat OUD during pregnancy and postpartum.
Ramage M, Bishop B, Mangano V, Mankabady B.   +3 more
europepmc   +2 more sources

A Real-World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database. [PDF]

Cancer Med
ABSTRACT Background Fruquintinib is a highly selective small‐molecule inhibitor that targets vascular endothelial growth factor receptors and is approved for the treatment of metastatic colorectal cancer. Given its increasing clinical adoption, a comprehensive pharmacovigilance evaluation of the adverse events (AEs) is warranted.
Xu Y, Wang D, Xu Y.
europepmc   +2 more sources

A Guide for Initiating and Managing Chimeric Antigen Receptor T Cell Therapy Clinical Trials in Autoimmune Rheumatic Diseases. [PDF]

ACR Open Rheumatol
Chimeric antigen receptor (CAR) T‐cell therapy, long transformative in oncology, is now rapidly emerging as a frontier in autoimmune rheumatic diseases, particularly systemic lupus erythematosus (SLE), driven by accumulating evidence of deep B‐cell depletion, immune “resetting,” and durable drug‐free remission in early studies, yet its translation into
Caricchio R, Bell S, Bernatsky S, Dall'Era M, Goddard D, Kalunian K, Kim AHJ, Koumpouras F, Rubio J, Saxena A, Sheikh S, Lupus Clinical Investigators Network.   +11 more
europepmc   +2 more sources

Postmarketing Surveillance for "Modified-Risk" Tobacco Products [PDF]

Nicotine & Tobacco Research, 2011
The U.S. Food and Drug Administration (FDA) acquired authority to regulate tobacco products in 2009. This authority will provide a structured process for manufacturers to introduce products that may have "modified-risk" for morbidity or mortality relative to traditional tobacco products, with postmarketing surveillance and studies a condition of ...
openaire   +2 more sources

Product-to-product differences in plasma concentration-time curves from recommended doses of prolonged-action preparations of theophylline

South African Family Practice, 1985
No abstract available.
R.S. Summers
doaj   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]

, 2010
Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y., Fogg, Carole, Layton, D., Shakir, S.   +3 more
core   +1 more source