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Writing Pediatric Study Plans (PSPs) – The Impact of the Revised 2016 FDA Draft Guidance

Children make up approximately one-quarter of the world’s population, but despite this the majority of drugs used in children are usually prescribed ‘off-label’ and have not undergone rigorous
testing within this population for safety and efficacy in well-controlled clinical trials. In this article, Diana Radovan and Rachel Beeby MSc at Trilogy Writing & Consulting discuss that drugs that work in adults may not necessarily work in children, and simply reducing the adult dose to account for children’s reduced weight erroneously assumes proportional safety and efficacy.