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EMA 关于帕利哌酮 3 个月注射剂的新报告:在没有充分证据基础的情况下做出临床和政策决策。

New EMA report on paliperidone 3-month injections: taking clinical and policy decisions without an adequate evidence base.

机构信息

Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry,University of Verona,Verona,Italy.

出版信息

Epidemiol Psychiatr Sci. 2017 Jun;26(3):231-233. doi: 10.1017/S2045796016001025. Epub 2016 Dec 22.

Abstract

Three-month long-acting paliperidone is a new, recently marketed, formulation of paliperidone, characterised by the longest available dosing interval among long-acting antipsychotics. The clinical profile of 3-month long-acting paliperidone was recently summarised by the European Medicines Agency (EMA) in a public assessment report, released in April 2016. In this commentary, the main strengths and limitations of the EMA assessment report were appraised and discussed, in order to highlight possible implications for clinical practice, future research and regulatory practices for drug approval.

摘要

三月长效帕利哌酮是一种新的、最近上市的帕利哌酮制剂,其特点是长效抗精神病药物中可用的最长给药间隔。欧洲药品管理局(EMA)于 2016 年 4 月发布了一份公开评估报告,对三月长效帕利哌酮的临床概况进行了总结。在这篇评论中,对 EMA 评估报告的主要优点和局限性进行了评估和讨论,以便突出对临床实践、未来研究和药物批准监管实践的可能影响。

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