. Author manuscript; available in PMC: 2021 Jun 1.

Published in final edited form as: J Pharmacokinet Pharmacodyn. 2020 Apr 22;47(3):199–218. doi: 10.1007/s10928-020-09684-2

Table 2.

Evaluated study designs for positive and negative-control studies

Number of Subjects^a	Samples per Subject^b
5	3	6	9
10	3	6	9
20	3	6	9
30	3	6	9

Successive (subject) groups contain observed subjects from previous groupings in addition new subjects

Collection intervals for the 3 sample time points were 10–15 minutes, 60–70 minutes, and 8–8.5 hours. For 6 sample time points, collection intervals were 10–15 minutes, 25–30 minutes, 60–70 minutes, 120–140 minutes, 8–8.5 hours, and 12–13 hours. For 9 sample time points, collection intervals were 1–3 minutes, 10–15 minutes, 25–30 minutes, 60–70 minutes, 120–140 minutes, 4–4.5 hours, 8–8.5 hours, 12–13 hours, and 22–24 hours (post-dose administration).