kywoo
第5楼2012/02/07
5.1. Repeatability
Repeatability should be assessed using:
a) a minimum of 9 determinations covering the specified range for the procedure (e.g., 3 concentrations/3 replicates each);
or
b) a minimum of 6 determinations at 100% of the test concentration.
5.2. Intermediate Precision
The extent to which intermediate precision should be established depends on the circumstances under which the procedure is intended to be used. The applicant should establish the effects of random events on the precision of the analytical procedure. Typical variations to be studied include days, analysts, equipment, etc. It is not considered necessary to study these effects individually. The use of an experimental design (matrix) is encouraged.
5.3. Reproducibility
Reproducibility is assessed by means of an inter-laboratory trial. Reproducibility should be considered in case of the standardization of an analytical procedure, for instance, for inclusion of procedures in pharmacopoeias. These data are not part of the marketing authorization dossier.