The critical need for postmarketing surveillance in gene therapy for haemophilia
Haemophilia, 2020 The goal of gene therapy for haemophilia is to alter the clinical phenotype to a milder form or even cure, by increasing endogenous coagulation factor levels through transfer of a functional gene encoding the respective deficient coagulation factor and ...
B. Konkle, M. Recht, A. Hilger, P. Marks
semanticscholar +1 more source
Journal of Arrhythmia, 2021 Background Direct oral anticoagulants (DOACs) are the recommended first‐line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF).
Takeshi Yamashita +3 more
doaj +1 more source
Stepwise approach of development of dermo‐cosmetic products in healthy and atopic dermatitis paediatric population: safety evaluation, clinical development and postmarket surveillance [PDF]
Journal of the European Academy of Dermatology and Venereology, 2019 AbstractBackground/objectivesPaediatric skin, considered sensitive, and infant skin, more susceptible to percutaneous toxicity, require specially formulated cosmetic products. As recently shown, early use of emollients in infants “at risk” of developing atopic dermatitis has shown controversial results in reducing the incidence of atopic dermatitis ...
V. Ribet +5 more
openaire +3 more sources
Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China
Journal of Epidemiology, 2014 China has long experience using live attenuated and inactivated vaccines against hepatitis A virus (HAV) infection. We summarize this experience and provide recent data on adverse events after immunization (AEFIs) with hepatitis A vaccines in China.
Weizhong Yang +5 more
openaire +4 more sources
Neonatal Safety Information Reported to the FDA During Drug Development Studies. [PDF]
, 2018 BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates
Ariagno, Ron +8 more
core +3 more sources
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
The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication. [PDF]
, 2016 PurposeTo explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.MethodsData from enrolling 27 cancer registries over a 10-year period were ...
Andrews, Elizabeth B +6 more
core +1 more source
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. +3 more
core +1 more source
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 +4 more
doaj +1 more source
A Blockchain-Based Post-Marketing Surveillance System for Medical Devices [PDF]
مجله علوم پزشکی صدراNowadays, medical devices are widely used around the world. In every country, the safety of these devices is inextricably related to public health and security.
Ali Tavakoli Golpaygani +2 more
doaj +1 more source