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

The cumulative percentage for a value of x is given by (1 – e-λx) and so the value of x corresponding to a required cumulative percentage (P) is x = –ln(1 – P) / λ. Thus, a 99.9% upper limit could be calculated by 6.91 / λ. If λ is estimated by the mean of the measurements, this is 6.91 times the mean.

More information about the Poisson and Exponential distributions can be found in the NIST/SEMATECH e-Handbook of Statistical Methods.3 Information about Solver, POISSON, and EXPONDIST is provided in Excel's Help option. Minitab provides the option to add an exponential distribution plot to a histogram.

REFERENCES

1. US Food and Drug Administration. International Conference on Harmonization; Guidance on specifications: Test procedures and acceptance criteria for biotechnological/biological products. Federal Register; 1999 Aug 19 [cited 2006 October 13];6(159):44934. Available from: http://www.fda.gov/cber/gdlns/ichtest.pdf

2. Deming WE. Some theory of sampling. NY: Dover Publications; 1966.

3. NIST/SEMATECH e-handbook of statistical methods. 2003 June 1 (updated 2006 July 18) [cited 2006 October 13]. Available from: http://www.itl.nist.gov/div898/handbook.

4. Howe WG. Two-sided tolerance limits for normal populations-some improvements. J of Am Statistical Assoc 1969;64:610-20.

5. Natrella MG. National Bureau of Standards handbook 91: Experimental statistics. Washington, DC: US Department of Commerce; 1963.

Excel procedures to apply all these methods can be obtained from

Terry Orchard is a statistician at Bespak Europe, Blackhill Dr., Featherstone Road, Wolverton Mill South, Milton Keynes, Buckinghamshire, MK12 5TS, England, + 44 (0)1908.552600, fax +44(0)1908.552613,


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

PDA Announces Technical Report on Drug Shortages
September 9, 2014
European Commission Approves RoACTEMRA for Treatment of RA
September 9, 2014
DPT Laboratories Acquires Media Pharmaceuticals' Lakewood Facilities
September 5, 2014
Merck KGaA Breaks Ground on Facility in China
September 5, 2014
FDA Releases Guidance Electronic Submission of Lot Distribution Reports
September 5, 2014
Author Guidelines
Source: BioPharm International,
Click here