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Download full textFood and Drug Administration (DHEW), Washington, DC. – 1979
These guidelines are intended to help those who design and conduct investigations of psychopharmacologic agents in children. A progression of studies in four phases is advocated. First, early short term studies should establish single and multiple dose safety baselines. Second, early pilot efficacy studies may be initiated jointly with longer…
Descriptors: Children, Drug Therapy, Evaluation Criteria, Evaluation Methods
