Results 41 to 50 of about 5,950 (190)
Clinical Pharmacology &Therapeutics, EarlyView.The U.S. Food and Drug Administration (FDA) used an Active Postmarket Risk Identification and Analysis (ARIA) system to address a safety issue (serious infection) identified during clinical review of an application to market ustekinumab as a treatment for Crohn's disease (CD). FDA used an active‐comparator new‐user cohort design, data from six Sentinel
Joel L. Weissfeld +9 more
wiley +1 more source
An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice [PDF]
, 2012 Background: Medication registration currently requires evidence of safety and efficacy from adequately powered phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting) provide data on more widespread and
Abernethy, Amy Pickar +4 more
core +1 more source
Future Postharvest and Food, EarlyView.The detection of toxins in baby food using artificial intelligence. ABSTRACT Infant foods and baby formulas are becoming increasingly popular across the globe owing to their ease of consumption and nutritional value specific to infants. Impurities may find their way into the food chain at any point from the acquisition of raw materials to final ...
Poornima Singh +3 more
wiley +1 more source
Revista Brasileira de Epidemiologia, 2011 OBJETIVOS: Descrever e avaliar o Sistema brasileiro de vigilância passiva de eventos adversos pós-vacinação (SPVEAPV). MÉTODOS: A descrição e avaliação do SPVEAPV fundamentaram-se nas notificações de eventos adversos pós-vacina Tetravalente ou DTwP/Hib -
Sandra Aparecida Moreira Gomes Monteiro +2 more
doaj +1 more source
Journal of Analytical Science and Technology, 2020 Venetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies.
Dhruvisha Pokar +2 more
doaj +1 more source
Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations [PDF]
Farmacia Hospitalaria, 2018 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
The US Food and Drug Administration’s expedited approval programs: addressing premarket flexibility with enhanced postmarket evidence generation [PDF]
, 2018 When the editors of Clinical Trials solicited our review on the U.S. Food and Drug Administration’s (FDA) expedited development and review programs, we anticipated there would be accompanying commentaries from other academics with differing opinions, or ...
Naci, Huseyin +2 more
core +2 more sources
Knee Surgery, Sports Traumatology, Arthroscopy, EarlyView.Abstract Purpose This registry study aimed to evaluate the safety and effectiveness of collagen membrane‐covered matrix‐associated autologous chondrocyte implantation (cMACI) versus periosteum‐covered MACI (pMACI) for large knee cartilage defects (Outerbridge III–IV, ≥4 cm²) in the femorotibial and/or patellofemoral joints with a minimum 2‐year follow ...
Yuji Uchio +4 more
wiley +1 more source
Archives of Medical ScienceIntroduction 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
INNOVATIONS in Pharmacy, 2016 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