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West Ashley Library
Closed (2024 - Labor Day)
Phone: (843) 766-6635
Folly Beach Library
Closed (2024 - Labor Day)
Phone: (843) 588-2001
Edgar Allan Poe/Sullivan's Island Library
Closed (2024 - Labor Day)
Phone: (843) 883-3914
Wando Mount Pleasant Library
Closed (2024 - Labor Day)
Phone: (843) 805-6888
Village Library
Closed (2024 - Labor Day)
Phone: (843) 884-9741
St. Paul's/Hollywood Library
Closed (2024 - Labor Day)
Phone: (843) 889-3300
Otranto Road Library
Closed (2024 - Labor Day)
Phone: (843) 572-4094
Mt. Pleasant Library
Closed (2024 - Labor Day)
Phone: (843) 849-6161
McClellanville Library
Closed (2024 - Labor Day)
Phone: (843) 887-3699
Keith Summey North Charleston Library
Closed (2024 - Labor Day)
Phone: (843) 744-2489
John's Island Library
Closed (2024 - Labor Day)
Phone: (843) 559-1945
Hurd/St. Andrews Library
Closed (2024 - Labor Day)
Phone: (843) 766-2546
Miss Jane's Building (Edisto Library Temporary Location)
Closed (2024 - Labor Day)
Phone: (843) 869-2355
Dorchester Road Library
Closed (2024 - Labor Day)
Phone: (843) 552-6466
John L. Dart Library
Closed (2024 - Labor Day)
Phone: (843) 722-7550
Baxter-Patrick James Island
Closed (2024 - Labor Day)
Phone: (843) 795-6679
Main Library
Closed (2024 - Labor Day)
Phone: (843) 805-6930
Bees Ferry West Ashley Library
Closed (2024 - Labor Day)
Phone: (843) 805-6892
Mobile Library
Closed (2024 - Labor Day)
Phone: (843) 805-6909
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Important Considerations for Signal Detection and Evaluation.
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- Author(s): Buchanan, James; Li, Mengchun
- Source:
Therapeutic Innovation & Regulatory Science; Jul2023, Vol. 57 Issue 4, p865-874, 10p- Subject Terms:
- Source:
- Additional Information
- Subject Terms:
- Abstract: Safety clinicians have a wealth of resources describing how to perform signal detection. Nevertheless, there are some nuances concerning approaches taken by regulatory authorities and statistical considerations that should be appreciated. New approaches, such as the FDA Medical Queries, illustrate the value of considering medical concepts over individual adverse events. One area which would benefit from further clarity is how safety signals may be evaluated for evidence of a causal relationship to the drug of interest. Just as such safety signals can take many forms, the types of tools and methods required to interrogate these signals are equally as diverse. An understanding of the complexity of this process can aid the safety reviewer in successfully characterizing the emerging safety profile of a drug during the pre-marketing phase of development. [ABSTRACT FROM AUTHOR]
- Abstract: Copyright of Therapeutic Innovation & Regulatory Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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