Results 51 to 60 of about 12,493 (244)

Reshaping study design for faster extrapolation‐based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN–NASPGHAN position paper

open access: yesJournal of Pediatric Gastroenterology and Nutrition, EarlyView.
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]

open access: yesمجله علوم پزشکی صدرا
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

open access: yesClinical Pharmacology &Therapeutics, Volume 119, Issue 2, Page 318-321, February 2026.
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

open access: yesINNOVATIONS in Pharmacy, 2021
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

open access: yesJournal of Cachexia, Sarcopenia and Muscle, Volume 17, Issue 1, February 2026.
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

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

open access: yesJournal 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

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

open access: yesFrontiers 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   +4 more
doaj   +1 more source

Value of Clinical Evidence and Health Economics and Outcomes Research (HEOR) Studies

open access: yesMuscle &Nerve, Volume 73, Issue S1, Page S7-S12, February 2026.
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]

open access: yes, 2017
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

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