关闭
 
读者在线:用户名 密码
首页 期刊简介 投稿须知 期刊目录 专家风采 编委会 特邀顾问 联系我们 移动出版
  1. 1
  2. 2
  3. 3
  4. 4
  5. 5



刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

访问统计
您是第  1 2 7 2 7 9 4 9 位浏览者
您当前的位置:首页 >> 正文

统计区间的作用及在药品质量控制中的应用

The effects of statistical intervals and their application in pharmaceutical quality control

作者: 张横, 谭德讲 
作者(英文):ZHANG Heng, TAN De-jiang
分类号:
出版年·卷·期(页码):2013,33 (11):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 系统介绍统计学区间的几个概念、作用及SAS软件的计算方法。方法: 通过举例阐述其在药品生产、检验工作中的实际应用价值。结果和结论: 统计区间在药品质量控制中具有非常广泛的应用价值,希望人们能更多地使用该方法作为工具,对药品的生产质量进行更好地监控和评估。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To systematically introduce the concept,effects of statistical intervals,and calculation methods of SAS software. Methods: Examples were given to illustrate the application of statistical intervals in pharmaceutical production and testing. Results and Conclusion: Statistical intervals are very useful indexes in pharmaceutical quality control as tools to be widely used for the control and/or evaluation of pharmaceutical production quality.

-----参考文献:---------------------------------------------------------------------------------------
1 Schwarz CJ.Sampling Regression Experimental Design and Analysis for Environmental Scientists,Biologists,and Resource Managers[DB/OL].2011[2012-05-06].http://people.stat.sfu.ca/~cschwarz/stat-650/Notes/PDF/Chapter 17.pdf
2 TAN De-jiang(谭德讲),MA Shuang-cheng(马双成).Statistical Applications in Pharmaceutical Regulatory Science(药品监督与检定中的统计学应用)[M].Beijing(北京):China Science and Technology Press(中国科学技术出版社),2011
3 Wikipedia:Interval estimation[DB/OL].[2013-09-13].http://en.wikipedia.org/wiki/Statistical_interval
4 Neyman J.Outline of a theory of statistical estimation based on the classical theory of probability[J].Philos T R Soc A,1937,236(767):333
5 Wikipedia:Prediction Interval[DB/OL].[2013-09-13].http://en.wikipedia.org/wiki/Prediction_interval
6 Wikipedia:Tolerance Interval[DB/OL].[2013-09-13].http://en.wikipedia.org/wiki/Tolerance_interval
7 ZHOU Wei(周暐),Quality management of the meaning and application of statistical interval (质量治理中统计区间的意义与应用)[DB/OL].[2013-09-13].http://www.chinabaike.com/z/xinxi/guanlizixun_renzheng/282976.html
8 Katki HA,Engels EA,Rosenberg PS.Assessing uncertainty in reference intervals via tolerance intervals-application to a mixed model describing HIV infection[J].Stat Med,2005,24(20):3185
9 USP35-NF30.2012.1010
10 "Tolerance intervals for a normal distribution".Engineering Statistics Handbook.NIST/Sematech.
2010[DB/OL].[2013-09-13].http://www.itl.nist.gov/div898/handbook/prc/section2/prc263.htm
11 Vardeman SB.What about the Other Intervals?[J].Am Stat,1992,46(3):193
12 Nelson MJ.You might want a tolerance interval[DB/OL].[2013-09-13].http://www.kmjn.org/notes/tolerance_intervals.html
13 Krishnamoorthy K.,Mathew T..
Statistical Tolerance Regions-Theory,Applications,and Computation[M].US:John Wiley and Sons,2009

欢迎阅读《药物分析杂志》!您是该文第 1439位读者!

药物分析杂志 © 2009
地址:北京天坛西里2号 邮政编码:100050; 电子邮件:ywfx@nicpbp.org.cn