Version | 1.0 |
File Size | 477 kb |
File Count | 1 |
Create Date | July 13, 2022 |
Update Date | July 13, 2022 |
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Summary of Post Marketing
Safety surveillance will be a part of a comprehensive post-marketing program to satisfy a regulatory requirement or to collect additional data to be used in drug development. The objectives of a security surveillance program are to assess and quantify known or suspected drug issues of safety, identify and characterize potential new risks following product marketing, and to observe product-use patterns. The common sorts of post-marketing surveillance are passive and active surveillance, stimulated reporting, comparative observational studies, targeted clinical investigations, and other descriptive studies.Post Marketing Safety Surveillance is a component of a comprehensive program. The objectives of a security surveillance program are to assess and quantify known or suspected drug issues of safety, identify and characterize potential new risks and risk factors following product marketing, and to observe medication use patterns. the info collected can improved the understanding of "real world" use of a product, and identifying off-label use and potential medication errors and detect new safety information.
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