Table 1.

Sample size estimates for observing time-related differences in basic hepatic function in experiments with OrganoPlate^® 2-lane 96 plates seeded with iHeps and non-parenchymal (vehicle-treated groups). Shown are the number of replicate devices needed for detecting significant (p<0.05 with 80% power) differences between timepoints or in a trend test.

Endpoint	Un-paired samples	Paired samples
Lactate dehydrogenase
Days 1–3 vs Days 14–17	66 (33/group)	28
Days 7–9 vs Days 14–17	20 (10/group)	9
Time trend (regression)	>100	>100
Albumin
Days 1–3 vs Days 4–6	26 (13/group)	13
Days 1–3 vs Days 7–9	20 (10/group)	10
Time trend (regression)	>100	>100
Urea
Days 1–3 vs Days 4–6	54 (27/group)	20
Days 1–3 vs Days 14–17	28 (14/group)	14
Time trend (regression)	33	>100
CYP3A4 activity
Days 4–6 vs Days 7–9	76 (38/group)	35
Days 4–6 vs Days 14–17	16 (8/group)	7
Time trend (regression)	65	>100