Safe and effective medicines for children : pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA), Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Marilyn J. Field and Thomas F. Boat, editors.
Introduction -- Children's growth and development and pediatric drug studies -- Policy framework for BPCA and PREA -- Ethical issues in pediatric drug studies -- Safety and efficacy assessment in studies conducted under BPCA and PREA -- BPCA, PREA, and drug studies with neonates -- Outcomes of written requests, requirements, studies, and labelling changes -- Pediatric studies of biologics.
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