An Alternative to the ESD Approach for Determining Sample Size and Test for Out-of-Specification Situations

被引：0
|
作者：
Andersen, Søren [1 ]
机构：
[1] Quality Support Department, Novo Nordisk A/S, Sauntesvej 13, 2820 Gentofte, Denmark
来源：
Pharmaceutical Technology | 2004年 / 28卷 / 05期
关键词：
Sampling; -; Testing;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
The ESD test has been recommended for outlier testing in OOS situations. In this article, the author presents the case for an alternative approach.
引用
收藏
页码：88 / 97
相关论文
共 48 条
  • [21] Determining sample size for a binary diagnostic test in the presence of verification bias
    Shan, Guogen
    Zhang, Hua
    Jiang, Tao
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2018, 28 (06) : 1193 - 1202
  • [22] Procedure for determining sample size at each stage in group sequential test
    Imada, Tsunehisa
    Douke, Hideyuki
    Communications in Statistics. Part B: Simulation and Computation, 2000, 29 (03): : 987 - 1000
  • [23] Determining Sample Size and a Passing Criterion for Respirator Fit-Test Panels
    Landsittel, D.
    Zhuang, Z.
    Newcomb, W.
    Ann, R. Berry
    JOURNAL OF OCCUPATIONAL AND ENVIRONMENTAL HYGIENE, 2014, 11 (02) : 77 - 84
  • [24] DETERMINING THE SAMPLE-SIZE FOR A HYBRID LIFE TEST BASED ON THE COST FUNCTION
    EBRAHIMI, N
    NAVAL RESEARCH LOGISTICS, 1988, 35 (01) : 63 - 72
  • [25] The power analysis technique in determining sample size for military equipment test and evaluation
    Bo, Yun
    Du, Zhiyuan
    Liao, Xuejun
    2019 7TH INTERNATIONAL FORUM ON INDUSTRIAL DESIGN, 2019, 573
  • [26] A GRAPHICAL APPROACH TO DETERMINING SAMPLE-SIZE FOR CANCER CLINICAL-TRIALS
    LEE, JY
    BIOMETRICS, 1982, 38 (04) : 1116 - 1116
  • [27] A score test for determining sample size in matched case-control studies with categorical exposure
    Sinha, S
    Mukherjee, B
    BIOMETRICAL JOURNAL, 2006, 48 (01) : 35 - 53
  • [28] Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!
    M. Lewis
    K. Bromley
    C. J. Sutton
    G. McCray
    H. L. Myers
    G. A. Lancaster
    Pilot and Feasibility Studies, 7
  • [29] Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!
    Lewis, M.
    Bromley, K.
    Sutton, C. J.
    McCray, G.
    Myers, H. L.
    Lancaster, G. A.
    PILOT AND FEASIBILITY STUDIES, 2021, 7 (01)
  • [30] ALTERNATIVE APPROACH TO DETERMINING THE PREFERRED PLANT SIZE OF PARABOLIC TROUGH CSP POWER PLANTS
    Sanchez, D.
    Frej, H.
    Munoz de Escalona, J. M.
    Chacartegui, R.
    Sanchez, T.
    PROCEEDINGS OF THE ASME TURBO EXPO 2011, VOL 3, 2012, : 1053 - 1062
12345