Specialised Scientific Disciplines Department, Quality of Medicines, European Medicines Agency (EMA), 7 Westferry Circus, Canary Wharf, London E14 4HB, United Kingdom.
Int J Pharm. 2014 Aug 5;469(2):245-8. doi: 10.1016/j.ijpharm.2014.03.057. Epub 2014 Apr 1.
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.
目前关于不同剂型适宜年龄的知识仍然零散或有限。申请人被要求证明目标年龄组（s）可以管理剂型或提出替代策略。然而，申请人必须走多远以及必须有多少患者认为该策略“可接受”仍存在疑问。本综述的目的是提供对该问题当前思维和理解的更新，并讨论与可接受性测试相关的问题。本综述应被视为开始更广泛讨论的一种手段，希望这将导致未来达成一种协调一致的、全球可接受的方法来确认可接受性。
