Table 4.

Equivalence testing method for determining sufficient similarity. Targeted chemistry data from unhydrolyzed samples was used to estimate the distance from the reference. Italicized values fall outside of the similarity region (> 3.77, the upper 95% confidence limit).

SAMPLE	Distance Estimatea	Upper 95% confidence limita	Comparison with positive and negative controlsb
GBE 1 (REF)	0	0	+
GBE 1F	0.05	0.09	+
GBE 1A	0.11	0.19	+
GBE W	0.32	0.56	+
GBE 1A*	0.35	0.63	+
GBE X	0.42	0.74	+
GBE Y	0.49	0.86	+
GBE Z	0.55	0.97	+
GBE U*	0.63	1.12	+
GBE K	0.72	1.28	+
GBE L	0.77	1.37	+
GBE Q	0.82	1.45	+
GBE O	0.83	1.47	+
GBE N	0.84	1.50	+
GBE T	0.85	1.52	+
GBE S	0.88	1.56	−/+
GBE J	0.89	1.58	−/+
GBE E	0.97	1.72	−/+
GBE D	0.99	1.75	−/+
GBE U	0.99	1.76	−/+
GBE I	1.01	1.79	−/+
GBE R	1.03	1.82	−/+
GBE P	1.53	2.72	−
GBE V	2.05	3.64	−
GBE A*	2.17	3.85	−
GBE G	2.20	3.90	−
GBE B*	2.25	3.99	−
GBE M*	2.28	4.05	−
GBE F*	2.28	4.06	−
GBE C*	2.32	4.12	−
GBE H*	2.54	4.52	−

^*Samples were evaluated in a separate targeted chemical analysis. Sample 1A and U were evaluated twice to account for run-to-run variability.

^aDistance measures and upper 95% confidence limit on the distance between the BMDs for the reference mixture and the sample mixtures.

^bThe dark green and dark red boxes indicate samples that were tested in vivo and had responses that were “similar” to or “different” from the reference response, respectively. The light green boxes represent an assumption of similarity and the light red boxes an assumption of difference. The yellow boxes represent an area of uncertainty between the tested samples. The plus symbols indicate similarity, the minus symbols indicate differences, and the plus/minus symbols indicate uncertainty.