What is it about?
The requirement for pharmaceutical sponsors to develop plans for studying children may seem logical but may in fact harm the interests of those it is meant to help.
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Why is it important?
Given the rarity of many diseases in children it may be logical to accept theory based extrapolation from adults rather than demanding specific paediatric trials. Current European legislation may actually be harming those it is meant to help.
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This page is a summary of: Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee-adolescents’ melanoma as a paradigm, Pharmaceutical Statistics, June 2014, Wiley,
DOI: 10.1002/pst.1623.
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