Regulatory perspectives on acceptability testing of dosage forms in children.

Research paper by Piotr P Kozarewicz

Indexed on: 08 Apr '14Published on: 08 Apr '14Published in: International Journal of Pharmaceutics


Current knowledge about the age-appropriateness of different dosage forms is still fragmented or limited. Applicants are asked to demonstrate that the target age group(s) can manage the dosage form or propose an alternative strategy. However, questions remain about how far the applicant must go and what percentage of patients must find the strategy 'acceptable'. The aim of this overview is to provide an update on current thinking and understanding of the problem, and discuss issues relating to the acceptability testing. This overview should be considered as means to start a wider discussion which hopefully will result in a harmonised, globally acceptable approach for confirmation of the acceptability in the future.