Literature Review of Safety Event Reporting in Observational Studies: Challenges Extrapolating across Comparable Products
Heather A. Ward,
Bao-Anh Nguyen-Khoa,
Robert Massouh
Abstract:Nirmatrelvir/ritonavir (PAXLOVIDTM, Pfizer) is an anti-infective inhibiting CYP3A4 indicated for the treatment of COVID-19 in adults at increased risk of severe COVID-19. As a newly approved product, PAXLOVID has limited safety information regarding rare events and serious adverse events (SAEs). This review describes the characterization of the real-world safety profile of products with similar pharmacological properties to PAXLOVID and aims to understand the impact of any drug interaction on the concomitantly… Show more
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