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Some paint containing lead remains, however, on the exteriors of homes painted before then, as well as in the interiors of homes painted before the 1950s, when lead paint was largely relegated to outdoor use because of emerging safety concerns.
This cross-national endeavor aims to facilitate identification and validation of emerging safety issues for pharmaceutical products across Asian countries.
Few have sought to define and evaluate processes for identification of emerging safety signals in longitudinal health data [ 11].
AsPEN provides a mechanism to support the conduct of cross-country pharmacoepidemiologic research to facilitate prompt detection and communication of emerging safety issues between countries.
To be able to identify reporting characteristics of emerging safety signals, a reference set of positive and negative controls was created.
Lastly, the reference standard consists of test cases that were publicly known during the time frame of our evaluation, and thus the performance may be altered when using the reference standard of emerging safety signals [ 47].
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The executive committee will be responsible for high-level decisions affecting the running of the trial (eg, closure of study sites, response to emerging safety issues), and will convene quarterly or more frequently, as required.
All the EU regulatory agencies monitor marketed products for emerging safety concerns using all sources of data available to them.
96 In the evaluation of many emerging safety issues, pharmacoepidemiological safety studies are discussed and may influence safety-related decision making.
Since vigiRank is a logistic regression model, once its coefficients have been estimated as described above, it can be used to make predictions for arbitrary drug ADR pairs regarding their likelihood of representing emerging safety signals.
In the meantime, the clinician and the woman herself need to balance the degree of severity of the depressive disorder and the risk of relapse, with the emerging safety profile of the individual SSRI.
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