Paediatric Medicines: Regulatory and Scientific Issues

Drug Research
Chrysa Daousani, Vangelis D Karalis

Abstract

In the past, dosage regimens authorized for adults were extrapolated to children relying mainly on empirical dosage adjustments. However, children are not small adults, but a distinct and heterogeneous group in terms of physiology, disease occurrence, pharmacokinetics, pharmacodynamics and also psychological, cognitive, and behavioral aspects. Even though it would be helpful to know the physiological changes and the special drug treatment needs in children, this task could not be performed due to ethical reasons. Important issues to consider for the development of paediatric drug products refer to the administration of the accurate dose, the use of the appropriate excipients, and acceptability. The latter is crucial and taste-screening methods (like electronic tongues) have been developed. A new era in paediatric medicines started with the entry into force of paediatric regulations. In the early '80s, the FDA started the set-up of a regulatory framework by authorizing issues like the Paediatric Rule, the Best Pharmaceuticals for Children Act, the Paediatric Research Equity Act, and the Food and Drug Administration Safety and Innovation Act. Similar efforts have been made in the EU, mainly through the entry into force of the Pae...Continue Reading

Citations

Apr 4, 2021·Pharmaceutics·Khadija RouazEncarna García-Montoya

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