ELIZA

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383385 occurrences (No.47 in the rank) during 5 years in the PubMed. [no cache] 500 found

374) We discuss gaps in existing approaches and identify areas where methodological development is needed to improve the success of safety surveillance efforts in this setting.

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PMID:22138688 DOI:10.1177/0962280211413452

2015 Statistical methods in medical research

* Methods for observational post-licensure medical product safety surveillance.

- Post-licensure medical product safety surveillance is important for detecting adverse events potentially not identified pre-licensure. Historically, post-licensure safety monitoring has been accomplished using passive reporting systems and by conducting formal Phase IV randomized trials or large epidemiological studies, also known as safety surveillance or pharmacovigilance studies. However, crucial gaps in the safety evidence base provided by these approaches have led to high profile product withdrawals and growing public concern about unknown health risks associated with licensed products. To address the limitations of existing surveillance systems and to facilitate more accurate and rapid detection of safety problems, new systems involving active surveillance of large, population-based cohorts using observational health care databases are being developed. In this article, we review common statistical methods that have been employed previously for post-licensure safety monitoring, including data mining and sequential hypothesis testing, and assess which methods may be promising for potential use within this newly proposed prospective observational cohort monitoring framework. We discuss gaps in existing approaches and identify areas where methodological development is needed to improve the success of safety surveillance efforts in this setting.

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(1)236 of	(6)6 was	(11)3 and/or	(16)2 on
(2)59 and	(7)5 as	(12)3 by	(17)2 progression,
(3)54 null	(8)4 are	(13)3 including	(18)2 to
(4)21 in	(9)4 for	(14)3 process
(5)6 is	(10)4 were	(15)2 after

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--- WordNet output for development --- =>発達, 開発, 産物, 進展 Overview of noun development The noun development has 9 senses (first 7 from tagged texts) 1. (52) development -- (act of improving by expanding or enlarging or refining; "he congratulated them on their development of a plan to meet the emergency"; "they funded research and development") 2. (46) development, evolution -- (a process in which something passes by degrees to a different stage (especially a more advanced or mature stage); "the development of his ideas took many years"; "the evolution of Greek civilization"; "the slow development of her skill as a writer") 3. (11) growth, growing, maturation, development, ontogeny, ontogenesis -- ((biology) the process of an individual organism growing organically; a purely biological unfolding of events involved in an organism changing gradually from a simple to a more complex level; "he proposed an indicator of osseous development in children") 4. (9) development -- (a recent event that has some relevance for the present situation; "recent developments in Iraq"; "what a revolting development!") 5. (7) exploitation, development -- (the act of making some area of land or water more profitable or productive or useful; "the development of Alaskan resources"; "the exploitation of copper deposits") 6. (6) development -- (a district that has been developed to serve some purpose; "such land is practical for small park developments") 7. (4) development -- (a state in which things are improving; the result of developing (as in the early part of a game of chess); "after he saw the latest development he changed his mind and became a supporter"; "in chess your should take care of your development before moving your queen") 8. development, developing -- (processing a photosensitive material in order to make an image visible; "the development and printing of his pictures took only two hours") 9. development -- ((music) the section of a composition or movement (especially in sonata form) where the major musical themes are developed and elaborated) --- WordNet end ---