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

Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
August 20, 2014
USP Center in Ghana Receives International Lab Accreditation
August 15, 2014
USP Awards Analytical Research
August 15, 2014
FDA Warns about Fraudulent Ebola Treatments
August 15, 2014
Guilty Plea to Importing Illegal Cancer Drugs
August 15, 2014
Author Guidelines
Source: BioPharm International,
Click here