Table 6.

Assessment criteria of the reliability of the hepatocyte stability negative control data

Passing criteria		Rationale
1	(a) t = 0 negative control within 20% of nominal concentration	(a) Reliability of quantification
	and/or	and/or
	(b) t = 0 negative control within 20% of t = 0 assay concentration	(b) Representative negative controls
2	Relative standard deviation (or CV%) <20% for t = 0 negative control	Reliability of quantification
3	<20% change in negative control over experiment	Negative control consistency, nonmetabolic losses ruled out