Dillard R F
Pharmacia, Skokie, IL 60077, USA.
Dev Biol (Basel). 2002;107:117-27.
Statistics has a role to play in the establishment of specification limits. This is particularly true in bioassays where the levels of uncertainty in the process and assay can be substantial. The use of statistical approaches can aid manufacturers in setting meaningful specifications and help to evaluate the ability of their processes to meet specifications long-term.
统计学在确定规格限度方面发挥着作用。在生物测定中尤其如此,因为该过程和测定中的不确定度水平可能很大。使用统计方法可以帮助制造商设定有意义的规格,并有助于评估其工艺长期满足规格的能力。