...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels
【24h】

Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels

机译：在FDA批准的产品标签中评估肝功能损害剂量建议

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Pharmacokinetic (PK) studies in patients with liver disease are an important clinical pharmacology component of drug development. In 2003, FDA released the guidance for industry on "Pharmacokinetics in Patients with Impaired Hepatic Function," which provides recommendations to sponsors on study design, data analysis, and impact on dosing and labeling. We evaluated the quality and consistency of hepatic dosing recommendations, and compared contemporary clinical practice of dosing in patients with impaired hepatic function with product labels. All new molecular entities (NME) and labels approved by the FDA during the period of January 2004 to December 2011 were reviewed. The fraction of the dose hepatically eliminated, quality of hepatic impairment PK studies reported, and any dose recommendations provided in the label and in a tertiary clinical reference (Micromedex) were reviewed. Out of 157 NMEs, 67 met the criteria for evaluation of dosing in hepatic disease. Problem areas were identified related to the lack of specific hepatic metabolism information in 90% of FDA-approved labels, inconsistent terminology, and "use with caution in liver disease" in 27% of NME. Updating the FDA guidance on PK studies in patients with impaired hepatic function could provide a standardized approach to improve the clinical usefulness of this dosing information for practitioners.
机译：肝病患者的药代动力学（PK）研究是药物开发的重要临床药理学组成部分。 FDA在2003年发布了针对“肝功能受损患者的药代动力学”的行业指南，该指南为研究设计，数据分析以及对剂量和标签的影响向申办者提供了建议。我们评估了肝给药建议的质量和一致性，并将肝功能受损患者的现代临床给药实践与产品标签进行了比较。审查了FDA在2004年1月至2011年12月期间批准的所有新分子实体（NME）和标签。回顾了肝清除剂量的分数，报告的肝功能损害PK研究质量以及标签和第三次临床参考文献（Micromedex）中提供的任何剂量建议。在157个NME中，有67个符合评估肝病用药标准。 90％的FDA批准标签中缺少特定的肝代谢信息，术语不一致以及27％的NME中“谨慎使用肝病”，这些都是相关的问题区域。更新FDA在肝功能受损患者中进行PK研究的指南可为改善该剂量信息对从业者的临床实用性提供标准化方法。

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