Over deze norm
1.1 This practice provides statistical methodology for conducting equivalence testing on numerical data from two sources to determine if their true means are similar within predetermined limits.
1.2 Applications include (1) equivalence testing for bias against an accepted reference value, (2) determining equivalence of two test methods, test apparatus, instruments, reagent sources, or operators within a laboratory, and (3) equivalence of two laboratories in a method transfer.
1.3 The current guidance in this standard applies only to experiments conducted on a single material. Guidance is given for determining the amount of data required for an equivalence trial.
1.4 The statistical methodology for determining equivalence used is the “Two one-sided t-test” (TOST). The control of risks associated with the equivalence decision is discussed.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
|Engelse titel||Standard Practice for Conducting Equivalence Testing in Laboratory Applications|