Formulating medicines for children: It is not a child's play

[Speaker] Catherine Tuleu:1
1:University College London School of Pharmacy, UK

Children have the right to access medicines that are appropriate to their unique needs and have adequate assurance of their quality, as much as efficacy and safety. This has been widely acknowledged worldwide and prompted legislative changes as well as global initiatives that have transformed this once niche area into an integral part of the drug development process that requires adequate understanding of relationship between medicine pharmaceutical design and how child's growth affects the medicine's usability in daily practice.
There has been a lack of evidence to guide the design of age-appropriate and acceptable dosage forms and resulted in a longstanding knowledge gap in paediatric formulation development. The Paediatric Regulation in Europe (2017) was introduce to stimulate the development of paediatric medicines but also to provide more information on their use, as a response to the lack of evidence and approval of medicines for children. In fact similar initiatives started in the 80s in the USA.
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