Výsledky vyhledávání - "Brian M. Overstreet"

Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors

Autor: Keith B. Hoffman, Mo Dimbil, Brian M. Overstreet, Abril Verden, 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

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A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes

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

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The Weber effect and the United States Food and Drug Administration's Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010

Autor: Keith B. Hoffman, Brian M. Overstreet, Nicholas P. Tatonetti, Mo Dimbil, Colin B. Erdman

Publikováno v: Drug Safety

Background The United States Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to approved drugs. The database is widely used to support post-marketing safety surveillance prog

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5ca98531469bc5c44e92d3baaec7546
https://pubmed.ncbi.nlm.nih.gov/24643967

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Erratum to: The Weber Effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): Analysis of Sixty-Two Drugs Approved from 2006 to 2010

Autor: Keith B. Hoffman, Mo Dimbil, Colin B. Erdman, Nicholas P. Tatonetti, Brian M. Overstreet

Publikováno v: Drug Safety

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1a12b80c6f084488056bf0fcd7ac83c3
http://europepmc.org/articles/PMC4643557

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Development of a drug safety ePlatform for physicians, pharmacists, and consumers based on post-marketing adverse events

Autor: P. Murali Doraiswamy, Keith B. Hoffman, Brian M. Overstreet

Publikováno v: Drugs and Therapy Studies. 3:4

Rigorous clinical trials under the watchful eye of regulators remain the cornerstone of drug safety. However, the emergence of serious and life-threatening Adverse Events (AEs) across best-selling drug classes [sometimes many years after winning Food

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a51f8f5badd58fbd50d26e1180d4b0c7
https://doi.org/10.4081/dts.2013.e4

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