A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration - Liu, Xiaomei I.; Schuette, Paul; Burckart, Gilbert J.; Green, Dionna J.; La, Julie; Burnham, Janelle M.; Rakhmanina, Natella; Robb, Adelaide; Huang, Shiew Mei; van den Anker, John N. (The Journal of pediatrics, 2019)
Keywords: Adolescent; Adult; adverse drug effects; antidepressant; Antidepressive Agents - adverse effects; antipsychotic; Antipsychotic Agents - adverse effects; Child; Clinical Trials as Topic; drug development; Drug-Related Side Effects and Adverse Reactions - epidemiology; Humans; Incidence; Patient Safety; pediatric; Pediatrics; regulatory; Risk; United States; United States Food and Drug Administration; US FDA; United States; FAERS; FDA; RD; adverse drug effects; regulatory; antidepressant; drug development; antipsychotic; US FDA; pediatric; ADR