Results 61 to 70 of about 6,056 (173)
Regulating risks in pharmaceutical law : the need of an optimal interplay between products safety and products liability [PDF]
Published online: 7 June 2011The aim of this paper is to call for the need of a theoretical model of pharmaceutical products safety in which the two systems of regulation and liability operate complementarily. The question is why two legal tools that are
RIZZI, Marco
core
Recent advances: rheumatology [PDF]
No abstract ...
Madhok, R., Kerr, H., Capell, H.A.
core +4 more sources
Objective A cardiovascular safety issue has been associated with JAK inhibitors (JAKi). This study compares the effects of distinct approved JAKi on endothelial cell (EC) dysfunction and apoptosis during inflammation. Methods Massive inflammation was induced in human vascular ECs by tumor necrosis factor (TNF) with interleukin‐17A (IL‐17A) treated or ...
Aliki Zavoriti, Pierre Miossec
wiley +1 more source
Adverse drug reactions induced by cardiovascular drugs in outpatients
Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs) induced by this class of medicinal products seems necessary.Objectives: To ...
Gholami K, Ziaie S, Shalviri G
doaj
Introduction Considering lack of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions (AEs) to secure a ...
Maciej Banach +9 more
doaj +1 more source
The Science of Safety – An Emerging Concept in Medication Use and Research
Most published reports of patient safety in clinical practice focus largely on the culture of safety in complex health systems, separate from pre-approval and postmarketing research-related safety considerations for drugs, biologics, and other medical ...
Shraddha Shinde, MBA student +1 more
doaj +1 more source
Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations [PDF]
Objective: To know the safety profile of the 4CMenB vaccine in adults in special situations. Method: Security prospective study of phase IV. Inclusion criteria and some vaccination conditions were applied.
María Fernández-Prada +5 more
doaj +1 more source
Self-controlled case series with multiple event types [PDF]
Self-controlled case series methods for events that may be classified as one of several types are described. When the event is non-recurrent, the different types correspond to competing risks.
Douglas, Ian J. +4 more
core +1 more source
Completeness of spontaneously reported adverse drug reactions in 4 databases
Aims To assess the completeness of information provided in adverse drug reaction (ADR) reports in 4 spontaneous report databases. Methods The study was conducted using freely accessible ADR reports from the Canada Vigilance Adverse Reaction Online Database, the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, the UK ...
Mohammed Gebre Dedefo +5 more
wiley +1 more source
Drug therapeutic failures as a cause of admission to an intensive care unit at a university hospital
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

