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| FDA的“致幻药：临床研究考虑因素的供企业用的指导原则”介绍 |
| Introduction to FDA"s Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry |
| 投稿时间：2023-10-18 修订日期：2024-07-23 |
| DOI： |
| 中文关键词: 美国食品药品管理局(FDA) 致幻药 治疗 精神心理疾病 临床研究 指导原则 |
| 英文关键词: US Food and Drug Administration (FDA) psychedelic drug treatment mental and psychological disorder clinical investigation guidance |
| 基金项目: |
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| 摘要点击次数: 15 |
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| 中文摘要: |
| 近年来国外致幻药在精神心理疾病治疗应用的研究越来越多,在抑郁症、物质使用障碍(包括酒精、烟草和各种药物成瘾)等方面取得了令人鼓舞的初步成果。美国食品药品管理局(FDA)于2023年6月发布了“致幻药：临床研究考虑因素的供企业用的指导原则”。为开发用于治疗疾病的致幻药的研究者,提供了一般的考虑因素。该指导原则“讨论”项目被分为5个小项,包括化学、生产和控制、非临床试验、临床药理学、滥用可能性评估和临床试验,讨论了这类药物开发可能面临的特殊挑战和应对措施。详细介绍FDA该指导原则,期望对我国这类新药的开发、研究和监管以及制定相应技术指导原则有帮助。 |
| 英文摘要: |
| In recent years, there has been increasing research on the application of psychedelic drugs in the treatment of mental and psychological disorders abroad, and encouraging preliminary results have been achieved in areas such as depression and substance use disorders (including alcohol, tobacco, and various drug addictions). The US Food and Drug Administration (FDA) issued Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry in June 2023. For researchers developing psychedelic drugs for treatment of medical conditions, general considerations are provided. The DISCUSSION section of this guidance is divided into 5 subsections, including Chemistry, Manufacturing, and Controls, Nonclinical, Clinical Pharmacology, Abuse Potential Assessment, and Clinical. It discusses the special challenges and response measures that may be faced by the development of such drugs. The FDA guidance have been introduced in detail, hoping to be helpful for the development, research, regulation, and formulation of corresponding technical guidances for this type of new drug in China. |
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