Author: Kleinman, Steve; Stassinopoulos, Adonis
Title: Risks associated with red blood cell transfusions: potential benefits from application of pathogen inactivation Document date: 2015_8_25
ID: qlddzgbg_25
Snippet: Licensure of PI-RBCs or PI-WB requires in vitro studies of RBC quality during storage, in vitro inactivation studies for representative transfusion-transmitted pathogens, in vivo recovery and survival studies of transfused RBCs in healthy volunteers to validate the maximum allowable length of product storage, and clinical trials of safety and efficacy in relevant patient populations. After licensure, postmarketing hemovigilance studies will allow.....
Document: Licensure of PI-RBCs or PI-WB requires in vitro studies of RBC quality during storage, in vitro inactivation studies for representative transfusion-transmitted pathogens, in vivo recovery and survival studies of transfused RBCs in healthy volunteers to validate the maximum allowable length of product storage, and clinical trials of safety and efficacy in relevant patient populations. After licensure, postmarketing hemovigilance studies will allow the further characterization of PI-RBC safety and efficacy.
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