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

Baxter Initiates Voluntary Recall of Potassium Chloride Injection
September 17, 2014
PDA Announces Technical Report on Drug Shortages
September 9, 2014
European Commission Approves RoACTEMRA for Treatment of RA
September 9, 2014
FDA Releases Guidance Electronic Submission of Lot Distribution Reports
September 5, 2014
Infinity and AbbVie Collaborate to Develop Oncology Drug
September 5, 2014
Author Guidelines
Source: BioPharm International,
Click here