Results 31 to 40 of about 21,353 (254)

Linked health data for pharmacovigilance in children : Perceived legal and ethical issues for stakeholders and data guardians [PDF]

open access: yes, 2014
Peer reviewedPublisher ...
Bond, Christine M   +4 more
core   +2 more sources

Drug therapeutic failures as a cause of admission to an intensive care unit at a university hospital

open access: yesJournal of Research in Pharmacy Practice, 2019
Objective: Drug therapeutic failures (TFs) are included in pharmacovigilance reporting, as some authors consider them a type of adverse drug reaction.
Jair Antonio Ruiz-Garzon   +2 more
doaj   +1 more source

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

open access: yesClinical and Translational Science, 2022
Clinical pharmacology is an integral discipline supporting the development, regulatory evaluation, and clinical use of drugs for the treatment of both common and rare diseases.
Julie Hsieh   +4 more
doaj   +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

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

open access: yesBMC Medicine, 2019
Background Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation.
Joshua D. Wallach   +4 more
doaj   +1 more source

Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland

open access: yesSwiss Medical Weekly, 2021
AIM OF THE STUDY In the era of pangenotypic treatment regimens against hepatitis C virus (HCV) infection, data from postmarketing observational studies are crucial to better understand the treatment patterns used in specific countries and ...
Beat Müllhaupt   +7 more
doaj   +1 more source

Macrophage Activation Syndrome as Onset of Systemic Lupus Erythematosus: A Case Report and a Review of the Literature [PDF]

open access: yes, 2015
Macrophage activation syndrome (MAS) is a potentially fatal condition. It is a rare complication of several autoimmune disorders, including systemic lupus erythematosus (SLE) and systemic juvenile idiopathic arthritis (sJIA).
Didona, Dario   +4 more
core   +4 more sources

Improving the clinical value and utility of CGM systems: issues and recommendations : a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group [PDF]

open access: yes, 2017
The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual.
Bergenstal, Richard M.   +5 more
core   +4 more sources

Mood, Personality, and Behavior Changes During Treatment with Statins: A Case Series. [PDF]

open access: yes, 2015
Psychiatric adverse drug reactions (ADRs) have been reported with statin use, but the literature regarding statin-associated mood/behavioral changes remains limited.
Cham, Stephanie   +2 more
core   +1 more source

Simvastatin: A Risk Factor for Angioedema? [PDF]

open access: yes, 2013
Objective. To report a case of simvastatin-induced angioedema in a patient with near nightly episodes of orofacial angioedema. Case Summary. A 75-year-old African American female presented to the emergency department with recurrent face, lip, and tongue ...
Kara, Areeba   +2 more
core   +2 more sources

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