Safety monitoring of ophthalmic biologics: a systematic review of pre- and postmarketing safety data.
作者： Ana Penedones , Diogo Mendes , Carlos Alves , Francisco Batel Marques
关键词: Safety monitoring 、 Methodological quality 、 Clinical trial 、 Randomized controlled trial 、 Adverse effect 、 Pharmacology 、 Observational study 、 Checklist 、 MEDLINE 、 Emergency medicine 、 Medicine
摘要: Abstract Purpose: The present study evaluates the safety of biologics approved for treatment ocular diseases. Methods: European medicines agency Website was searched to identify with ophthalmologic therapeutic indications. A systematic search performed using MEDLINE, Cochrane Central Register Controlled Trials (CENTRAL) and International Clinical Registry Platform up December 2013. Pre-marketing, phase III randomized controlled trials (RCT), postmarketing clinical trials, observational longitudinal studies, case reports involving adverse events (AE) were included. Methodological quality assessed by Downs & Black checklist. All spontaneous AE included in Eudravigilance 2013 also considered. classified as (related non-related injection procedure) non-ocular or vascular endothelial growth factor inhibition). Incidences all reported AEs wer...
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