大麻介导的I期药物-药物相互作用研究设计框架。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY
Diana L Shuster, Gina Pastino, Dirk Cerneus
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引用次数: 1

摘要

与许多其他国家一样,大麻在美国大部分地区已经合法化,无论是娱乐用途还是医疗用途。大麻产品的使用正在迅速增加,而对其无数影响的知识体系仍然滞后。体外和临床数据表明,大麻的主要成分δ -9-四氢大麻酚和大麻二酚会影响其他药物的药代动力学(PK)、安全性和药效学(PD)。在临床药物开发的背景下,大麻产品的广泛和频繁使用基本上创造了另一个特殊人群:大麻使用者。我们建议所有临床药物开发项目都包括一期研究,以评估大麻作为沉淀剂的药物-药物相互作用潜力,安全性,如果适用的话,所有新分子实体(NMEs)在健康成人受试者以及经常和不经常使用大麻的人身上的PD。应该要求这些数据为药品标签提供信息,并帮助卫生保健提供者治疗任何病人,因为大麻已迅速成为另一种常见的伴随药物和大麻使用者,一个新的特殊人群。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Framework for the Design of Cannabis-Mediated Phase I Drug-Drug Interaction Studies.

Cannabis has become legal in much of the United States similar to many other countries, for either recreational or medical use. The use of cannabis products is rapidly increasing while the body of knowledge of its myriad of effects still lags. In vitro and clinical data show that cannabis' main constituents, delta-9-tetrahydrocannabinol and cannabidiol, can affect pharmacokinetics (PK), safety, and pharmacodynamics (PD) of other drugs. Within the context of clinical drug development, the widespread and frequent use of cannabis products has essentially created another special population: the cannabis user. We propose that all clinical drug development programs include a Phase 1 study to assess the drug-drug interaction potential of cannabis as a precipitant on the PK, safety, and if applicable, the PD of all new molecular entities (NMEs) in a combination of healthy adult subjects as well as frequent and infrequent cannabis users. This data should be required to inform drug labeling and aid health care providers in treating any patient, as cannabis has quickly become another common concomitant medication and cannabis users, a new special population.

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来源期刊
CiteScore
4.80
自引率
9.10%
发文量
55
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