Results 51 to 60 of about 12,493 (244)
Abstract Children with inflammatory bowel diseases (IBD) have limited access to the available advanced therapies, given the lengthy gap between adult and pediatric approval. We aimed to review key hurdles for pediatric trials and recommend practical solutions.
Dan Turner +21 more
wiley +1 more source
A Blockchain-Based Post-Marketing Surveillance System for Medical Devices [PDF]
Nowadays, 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
The Rising Misuse of Pharmacovigilance Reporting Systems: A Threat to Evidence‐Based Medicine
In recent years, different national and international regulatory authorities, notably the FDA, have made their adverse event repositories publicly available, offering user‐friendly dashboards. This has led to a large increase in low‐quality, poorly reported research using adverse event reporting databases (e.g., FDA’s Adverse Event Reporting System ...
Charles Khouri +7 more
wiley +1 more source
An Overview of COVID-19 Vaccine Safety and Post-marketing Surveillance Systems
The need for the safety monitoring of the COVID-19 vaccine is unprecedented. It is an ongoing process starting from different phases of clinical trials and continued to post-marketing to tackle the emergency used authorized COVID-19 vaccines across the ...
Manal Mohammed Younus +1 more
doaj +1 more source
Current Trends in Duchenne Muscular Dystrophy Research and Therapy: 3D Cardiac Modelling
ABSTRACT Duchenne muscular dystrophy (DMD), caused by dystrophin deficiency, presents a multifaceted challenge that affects both skeletal muscle function and cardiomyocyte homeostasis, causing progressive degeneration and life‐threatening cardiac complications by adolescence.
Marta Przymuszała +3 more
wiley +1 more source
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
Digital Therapeutics in Perspective: From Regulatory Challenges to Post-Marketing Surveillance
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 +4 more
doaj +1 more source
Views of healthcare professionals to linkage of routinely collected healthcare data : a systematic review [PDF]
Peer reviewedPublisher ...
Bond, C +4 more
core +2 more sources
Value of Clinical Evidence and Health Economics and Outcomes Research (HEOR) Studies
ABSTRACT Randomized controlled trials (RCTs) remain the gold standard for establishing the efficacy and safety of new treatments. However, clinical evidence derived from the systematic analysis of real‐world data generated through routine clinical practice can complement RCT data by offering insights into treatment performance in broader, more ...
Agessandro Abrahao +2 more
wiley +1 more source
Tapentadol extended release for the management of chronic neck pain [PDF]
BACKGROUND: The role of opioids in the management of chronic neck pain is still poorly investigated. No data are available on tapentadol extended release (ER).
Coluzzi, Flaminia
core +1 more source

