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Setting specifications for non-normally distributed data
1Ortho-McNeil Pharmaceutical, Raritan, New Jersey 08869, USA.
Journal of Biopharmaceutical Statistics
|March 10, 2000
Abstract:
In this paper, we focus on estimating an upper specification for non-normally distributed data. Cornish-Fisher expansions were exploited for derivations of the method. The method was applied for upper specification calculations of two particle-size data sets, and simulation studies were also performed to demonstrate the accuracy of the approximations. The method was also used to calculate the critical values for delta(min) for the Anderson-Hauck test for equivalence using bootstrap samplings. The main advantage of the method is in calculating specifications with limited data.