Estimation of the shelf-life of drugs with mixed effects models
作者: James J. ChenJing-Shiang HwangYi Tsong
作者单位: 1Division of Biometry and Risk Assessment National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas
2Institute of Statistical Science Academia Sinica, Taipei, Taiwan
3Division of Biostatistics Center for Drug Evaluation and Research, Foor and Drug Administration, Rockville, Maryland
刊名: Journal of Biopharmaceutical Statistics, 1995, Vol.5 (1), pp.131-140
来源数据库: Taylor & Francis Journal
DOI: 10.1080/10543409508835102
关键词: Confidence limitEM algorithmFixed effectsRandom
原始语种摘要: This paper proposes a normal mixed effects model for stability analysis. An EM algorithm is developed to compute the maximum likelihood estimates of regression coefficients of the fixed effects and random effects, and variance components. The likelihood ratio test is used for the preliminary testing of batch-to-batch variation. An example from a marketing stability study is given to illustrate the proposed procedure.
全文获取路径: Taylor & Francis  (合作)
影响因子:0.728 (2012)

  • drugs 药品
  • mixed 混合的
  • effects 海员自身物品
  • shelf 陆架