Main issue | Consequence |
---|---|
Lack of age-appropriate dose | Due to their smaller size children can require a lower dose yet the dose may not be readily available from the commercial adult product In addition, there may be limited clinical pharmacokinetic data upon which the paediatric dose is based |
Lack of age-appropriate formulation | The nature of the adult product may make this unsuitable for use in children, for example tablets that are too large to be swallowed whole and are unsuitable to be crushed or split |
Insufficient return on investment for development of a paediatric age-appropriate product | Due to the smaller population of paediatric patients and the economic situation in areas affected by NTDs there is limited scope for financial return on investment |