22 5

V ol. 22, No . 5

2005 9

H ebei Jour nal of Industr ial Science and T echno log y

Sept. 2005

: 1008-1534( 2005) 05-0299- 03

( 104 ,

050015)

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: O212. 1

: A

Applicat ion of st at ist ical m et hod in bulk hom ogeneity validat ion
YAO Z heng, MA L-i yu
( 104 Wo rksho p, N or th China Phar maceutical Co mpany L im ited, Shijiazhuang Hebei 050015, China)

Abstract: T his pa per pro bes into the pr oblem of how to cho ose stat istical method in bulk homog eneity v alidatio n. T hro ug h
co mpar ison on applicatio n co nditions and precisions o f three stat istical methods and calculat ions of practical cases, it is show n
that all of the three met ho ds hav e their ow n adv ant ages and disadvantages. Conclusion: hypqthesis test ing is mo st co mmonly
used in bulk homo geneity v alidation. H ow ever, other metho ds may also be applied in lig ht o f practical circumstances.

Key words: bulk; ho mog eneit y; v alidation; statistical method; hypothesis testing

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