Regulatory perspectives on acceptability testing of dosage forms in children.
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.
Specialised Scientific Disciplines Department, Quality of Medicines, European Medicines Agency (EMA), 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom. Electronic address: piotr.kozarewicz@ema.europa.eu.
Piotr
P
Kozarewicz
D002648:Child; D004304:Dosage Forms; D004345:Drug Industry / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D055697:Taste Perception
D004304:Dosage Forms; D004364:Pharmaceutical Preparations
Acceptability; Age-appropriateness; Child; Development; Dosage forms; Palatability