Beyond the label: ethical and clinical implications of off-label drug use in pediatric emergency care. [PDF]
Ital J PediatrColombo M, Plebani A, Agosti M.
europepmc +1 more source
Postmarketing Research for Opioid Abuse-Deterrent Formulations: A Narrative Review. [PDF]
J Pain ResWebster L, Gudin J, Green JL, Argoff CE.
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Postmarketing analysis of sotatercept: identifying serious unlabelled events. [PDF]
Open HeartCao Z, Xiao Q, Li X, Zhang H, Zhang M.
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Avacopan-Associated Hepatotoxicity: Clinical Signal, Liver Injury Patterns, and Plausible Mechanisms. [PDF]
CureusHerrera-Jiménez LG +3 more
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Postmarketing safety surveillance for GSK's AS01<sub>E</sub>-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study. [PDF]
BMJ OpenAdimadhyam S +19 more
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Safety Evaluation of Omniscan: An Observational Postmarketing Surveillance. [PDF]
CureusMahajan H +9 more
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From a pyramid to an amphitheatre (triangle to circle): embracing the totality of evidence for the postmarketing evaluation of the safety of therapeutic interventions. [PDF]
BMJ OpenShakir S, Lane S.
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FDA Adverse Event Reporting System (FAERS) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse Event Data Reported to FAERS. [PDF]
Clin Pharmacol TherPotter E, Reyes M, Naples J, Dal Pan G.
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The real-world safety evaluation of the selective NaV1.8 inhibitor suzetrigine: disproportionality analysis and flexible empirical bayes signals from FAERS with external triangulation. [PDF]
Front PharmacolLai K +6 more
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After the green light: Evaluating drugs in Phase IV studies.
Indian J PharmacolMeher BR, Mishra A.
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