Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA - Green, Dionna J; Burnham, Janelle M; Schuette, Paul; Liu, Xiaomei I; Maas, Brian M; Yao, Lynne; McCune, Susan K; Chen, Joseph; van den Anker, John N; Burckart, Gilbert J (Journal of clinical pharmacology, 2018)
Keywords: Adult; Child; Clinical Trials as Topic - statistics & numerical data; Drug Development; Endpoint Determination; Humans; Pediatrics; Treatment Outcome; United States; United States Food and Drug Administration - standards; United States; endpoints; clinical trials; US FDA; regulatory/scientific affairs; pediatrics