...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of pharmaceutical sciences. >Biowaiver monographs for immediate release solid oral dosage forms: cimetidine.
【24h】

Biowaiver monographs for immediate release solid oral dosage forms: cimetidine.

机译：速释固体口服剂型的生物豁免专着：西咪替丁。

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

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine's therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA) problems were also taken into consideration. On the basis of the overall evidence, a biowaiver can be recommended for cimetidine IR products, provided that the test product contains only those excipients reported in this paper in their usual amounts, and that the test and the comparator drug products both are "rapidly dissolving" as per BCS.
机译：文献资料与决定放弃体内生物等效性（BE）测试以批准含有西咪替丁的速释（IR）固体口服剂型有关。根据当前的生物制药分类系统（BCS），西咪替丁将被划为III类。西咪替丁的治疗用途和治疗指数，其药代动力学特性，与赋形剂相互作用的可能性有关的数据以及报告的BE /生物利用度（BA）问题也已考虑在内。根据总体证据，可以建议对西咪替丁IR产品使用生物豁免，但前提是该测试产品仅包含本文报道的通常含量的赋形剂，并且该测试产品和比较药物均“迅速溶解”。根据BCS。

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