Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Robert F. Kyle"'
Publikováno v:
Drug Safety. 41:357-361
The Janus kinase (JAK) inhibitor baricitinib is approved in Europe and Japan for the treatment of rheumatoid arthritis. In April 2017, the US FDA expressed concern about thromboembolic events (deep venous thrombosis [DVT] and pulmonary embolism [PE])
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::21fb5b5e89828329f8caca6099519acf
https://doi.org/10.1007/s40264-017-0622-2
https://doi.org/10.1007/s40264-017-0622-2
Publikováno v:
Drug Safety. 39:561-575
Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cef493eba8198c7b8ca963d06923b61a
https://doi.org/10.1007/s40264-016-0409-x
https://doi.org/10.1007/s40264-016-0409-x
Autor:
Nicholas P. Tatonetti, Mo Dimbil, Keith B. Hoffman, Colin B. Erdman, Andrea Demakas, Robert F. Kyle, Brian M. Overstreet, Dingguo Chen
Publikováno v:
Journal of managed carespecialty pharmacy. 21(12)
Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee93309bc571230fd853b3c74c0a3e97
https://pubmed.ncbi.nlm.nih.gov/26679963
https://pubmed.ncbi.nlm.nih.gov/26679963