• 主题
高级搜索  >
历史搜索 清空历史
首页> 美国卫生研究院文献>AAPS PharmSciTech >Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets
【2h】

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets

机译：设计质量II：定量风险分析在环丙沙星片制剂中的应用

代理获取
本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with respect to the design space, i.e., calculating the probability of failure for a given severity, are needed to fully characterize design space boundaries. Quantitative risk assessment methods in design and operational spaces are a significant aid to evaluating proposed design space boundaries. The goal of this paper is to demonstrate a relatively simple strategy for design space definition using a simplified Bayesian Monte Carlo simulation. This paper builds on a previous paper that used failure mode and effects analysis (FMEA) qualitative risk assessment and Plackett-Burman design of experiments to identity the critical quality attributes. The results show that the sequential use of qualitative and quantitative risk assessments can focus the design of experiments on a reduced set of critical material and process parameters that determine a robust design space under conditions of limited laboratory experimentation. This approach provides a strategy by which the degree of risk associated with each known parameter can be calculated and allocates resources in a manner that manages risk to an acceptable level.Electronic supplementary materialThe online version of this article (doi:10.1208/s12249-015-0349-2) contains supplementary material, which is available to authorized users.
机译：定性风险评估方法通常被用作确定设计空间边界的第一步。但是，需要对设计空间的风险进行定量评估，即计算给定严重性的失败概率，以全面表征设计空间的边界。设计和操作空间中的定量风险评估方法对评估建议的设计空间边界有很大帮助。本文的目的是演示使用简化的贝叶斯蒙特卡洛模拟方法设计空间的相对简单策略。本文基于先前的论文，该论文使用了失效模式和影响分析（FMEA）的定性风险评估以及Plackett-Burman设计的实验来识别关键的质量属性。结果表明，定性和定量风险评估的顺序使用可以将实验设计的重点放在减少的关键材料和工艺参数上，从而在有限的实验室实验条件下确定稳健的设计空间。这种方法提供了一种策略，通过该策略可以计算与每个已知参数相关的风险程度并以将风险管理到可接受水平的方式分配资源。电子补充材料本文的在线版本（doi：10.1208 / s12249-015- 0349-2）包含补充材料，授权用户可以使用。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
代理获取

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