Specification Setting: Setting Acceptance Criteria from Statistics of the Data - - BioPharm International

ADVERTISEMENT

Specification Setting: Setting Acceptance Criteria from Statistics of the Data


BioPharm International
Volume 19, Issue 11

If the result of a appears in cell B5 and that of b appears in cell B6, the value of MU is given by

= (NORMINV(0.99625,0,1) + SQRT((NORMINV(0.99625,0,1))^2 – B5*B6)) / B5........... [8]

Values for some sample sizes with C = 99% and D = 99.625% appear in Table 1. These values of C and D were selected so that the one-sided tolerance interval limits would be (x mean – 3 * s) and (x mean + 3 * s) when the sample size is around 250.

Two-sided multipliers (MUL) are calculated by Howe's method with C = 99% and D = 99.25% (in equation 1).

One-sided multipliers (MU / ML) are calculated by Natrella's method with C = 99% and D = 99.625% (in equations 3, 4, and 5).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

AbbVie/Shire Deal Officially Off
October 20, 2014
Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9
October 20, 2014
EMA Works to Speed Up Ebola Treatment
October 20, 2014
Lilly to Close Manufacturing Facility in Puerto Rico
October 17, 2014
BioReliance Introduces New Predictive Assays
October 17, 2014
Author Guidelines
Source: BioPharm International,
Click here