首页> 外文期刊>The journal of clinical psychiatry >Regulatory and Scientific Issues in Studies to Evaluate Sexual Dysfunction in Antidepressant Drug Trials
【24h】

Regulatory and Scientific Issues in Studies to Evaluate Sexual Dysfunction in Antidepressant Drug Trials

机译:评价抗抑郁药物试验中性功能障碍的研究中的法规和科学问题

获取原文
获取原文并翻译 | 示例
       

摘要

Objective: Sexual dysfunction is an important side effect of serotonergic antidepressants, as it often leads to treatment nonadherence. However, sexual dysfunction is often underestimated in clinical trials submitted in support of drug approval. This is because such assessments are based mainly on unsolicited reporting. As a result, the characterization of sexual adverse events has become an important component of many of the development programs for new antidepressants. The purpose of this article is to discuss US Food and Drug Administration's (FDA's) current thinking on possible approaches to characterizing the effects of drugs on sexual function in depression drug trials.
机译:目的:性功能障碍是5-羟色胺能抗抑郁药的重要副作用,因为它经常导致治疗不依从。但是,在支持药物批准的临床试验中,性功能障碍常常被低估了。这是因为此类评估主要基于未经请求的报告。结果,性不良事件的表征已成为许多新的抗抑郁药开发计划的重要组成部分。本文的目的是讨论美国食品和药物管理局(FDA)在抑郁症药物试验中表征药物对性功能影响的可能方法的最新思路。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱:kefu@zhangqiaokeyan.com

京公网安备:11010802029741号 ICP备案号:京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有
  • 客服微信

  • 服务号