摘要
美国食品药品管理局(FDA)于2018年5月发布了"考虑列入OTC专论的外用药活性成分的最大用量试验:研究要点和考虑的因素供企业用的指导原则"。最大用量试验(MUsT)是评估外用药体内生物利用度的标准方法,该指导原则对MUsT许多研究要点提出了具体的建议。详细介绍该指导原则的主要内容,期待对我国这方面的研究和监管有益。
FDA issued Maximal Usage Trialsfor Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations Guidance for Industry in May 2018. Maximal usage trial(MUsT) is a standard approach to assess the in vivo bioavailability of topical drug products. The guidance provides specific suggestions for many study elements of MUsT. This paper introduces the main contents of the guidance in detail, and expects to be beneficial to the research and supervision of this aspect in China.
作者
萧惠来
XIAO Huilai(Center for Drug Evaluation,State Drug Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2018年第10期1753-1758,共6页
Drug Evaluation Research
