Ontology highlight
ABSTRACT:
SUBMITTER: Vermeer NS
PROVIDER: S-EPMC6590109 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature
Vermeer Niels S NS Giezen Thijs J TJ Zastavnik Sofia S Wolff-Holz Elena E Hidalgo-Simon Ana A
Clinical pharmacology and therapeutics 20190111 4
Biologicals are established treatment options that require pharmacovigilance adapted to their specific nature, including the need for products to be identifiable up to the specific manufacturer in reports of adverse drug reactions (ADRs). This study explored the identifiability of 10 classes of similar and related biologicals up to the level of the manufacturer in ADR reports received from European clinical practice between 2011 and June 2016. Adequate identifiers were reported for 96.7% of the ...[more]