|
In the USP's Pharmacopeial Forum of July/August 2007, the Statistics Expert
Committee suggested several changes for General Chapter <1010> - "Analytical
Data - Interpretation and Treatment". Among them are:
-
an explanation for the correct implementation of the Dixon
test for identifying outliers
-
an additional statement in Appendix B on the topic of
precision explaining how the variance of the
mean value decreases and how - as a consequence - a test's precision can be
improved by increasing the number of individual measurements ("replicates")
within a test run
-
in the section "Measurement Principles and Variation", the
term "relative standard deviation" is changed to "per cent relative
standard deviation"
In the revision of the General Chapter, the term "reportable
value" has been included, which was already established officially in FDA's final OOS
Guideline in force since October 2006.
|
