Sanae Cherkaoui
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View article: The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes
The Impact of Variability in Patient Exposure During Premarket Clinical Development on Postmarket Safety Outcomes Open
We characterized the size of the premarket safety population for 278 small‐molecule new molecular entities (NMEs) and 61 new therapeutic biologics (NTBs) approved by the US Food and Drug Administration (FDA) between October 1, 2002, and De…
View article: Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities
Postmarketing Safety‐Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002–2014: Similarities and Differences With New Molecular Entities Open
We examined the relationship of regulatory and review characteristics to postmarketing safety‐related regulatory actions for 61 new therapeutic biologics (NTBs) approved between October 1, 2002 and December 31, 2014. We also compared NTBs …