Story M J, Winson J A, Beyer P L, Boehm G
J Biol Stand. 1986 Jul;14(3):249-54. doi: 10.1016/0092-1157(86)90010-7.
Large plate bioassays are normally assessed by analysis of variance. The British Pharmacopoeial approach requires a validation of the assay through a test for parallelism. This approach is shown to be impractical as it does not allow for improvements in technique which tend to reduce the error mean square value for the bioassay and hence increase the F ratio for parallelism. A new parallelism acceptance criterion is proposed in which a critical value for parallelism mean square is determined by multiplying the appropriate critical F value for parallelism by the value for error mean square which provides a limiting value for the fiducial limits. This approach allows for improved bioassay technique but does not lead to the acceptance of doubtful assay results. The results of 15 months of bioassays covering over 500 assays using the proposed parallelism acceptance criterion are discussed.
大平板生物测定通常通过方差分析进行评估。英国药典的方法要求通过平行性测试对测定进行验证。结果表明这种方法不切实际，因为它不允许技术改进，而技术改进往往会降低生物测定的误差均方值，从而提高平行性的F比率。本文提出了一种新的平行性验收标准，其中平行性均方的临界值通过将平行性的适当临界F值乘以误差均方值来确定，该误差均方值为置信限提供了一个极限值。这种方法允许改进生物测定技术，但不会导致接受可疑的测定结果。本文讨论了使用所提出的平行性验收标准进行的15个月生物测定的结果，涵盖了500多次测定。
