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Intro to Drug Safety & Pharmacovigilance Flashcards | StudBud
Intro to Drug Safety & Pharmacovigilance
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What is NOT correct about the content of the PSUR
A
Evaluation of product Risk/Benefit should be included
B
Table with Adverse Reaction should be split in different population
C
SAEs from clinical trials are included in a line listing
D
Only confirmed signals should be described
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