Multiple-time-point dissolution specifications for a sampling acceptance plan
作者: James J. ChenYi Tsong
作者单位: 1Division of Biometry and Risk Assessment, National Center for Toxicological Research Food and Drug Administration, Jefferson, Arkansas
2Division of Biometrics III, Center for Drug Evaluation and Research Food and Drug Administration, Rockville, Maryland
刊名: Journal of Biopharmaceutical Statistics, 1997, Vol.7 (2), pp.259-270
来源数据库: Taylor & Francis Journal
DOI: 10.1080/10543409708835185
关键词: Acceptance criteriaBonferroni confidence intervalsBoot- strap resamplingHotelling's T 2Simultaneous confidence intervals
原始语种摘要: In dissolution testing, multiple dissolution measurements at specific time points are used to obtain the dissolution characteristics for most extended- release and some immediate-release drug products. This paper presents a general procedure for defining specifications by a multivariate confidence region or by simultaneous confidence limits on the dissolution values of individual time points. The confidence regions and simultaneous confidence limits were estimated using two approaches: the first approach assumed a multivariate normal distribution on the multiple dissolution values and the second approach used the bootstrap resampling method. The multivariate confidence region was constructed using the Hotelling's T2 statistic (equivalently, Mahalanobis distance D2), and the simultaneous...
全文获取路径: Taylor & Francis  (合作)
影响因子:0.728 (2012)

  • specifications 技术条件
  • dissolution 溶解
  • sampling 取样
  • point 
  • acceptance 接收